Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

ASPIRATOR

Model 798-0330-02-01 · Zoll Medical Corporation · DI 00847946050559

BTA — Pump, Portable, Aspiration (Manual Or Powered) · Class II · 21 CFR 878.4780

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

61319262019-02: 0 reports for this device; peer average 4.33/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 1.5/device2019-05: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 3.5/device2019-07: 0 reports for this device; peer average 3.33/device2019-08: 0 reports for this device; peer average 4/device2019-09: 0 reports for this device; peer average 1.5/device2019-10: 0 reports for this device; peer average 3/device2019-11: 0 reports for this device; peer average 13/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 3.6/device2020-02: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 1.5/device2020-04: 0 reports for this device; peer average 2.33/device2020-05: 0 reports for this device; peer average 1.5/device2020-07: 0 reports for this device; peer average 2/device2020-08: 0 reports for this device; peer average 3/device2020-09: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 4/device2020-11: 0 reports for this device; peer average 3/device2020-12: 0 reports for this device; peer average 4/device2021-01: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 4/device2021-04: 0 reports for this device; peer average 5/device2021-05: 0 reports for this device; peer average 3/device2021-06: 0 reports for this device; peer average 4/device2021-07: 0 reports for this device; peer average 3/device2021-08: 0 reports for this device; peer average 13/device2021-09: 0 reports for this device; peer average 25.5/device2021-10: 0 reports for this device; peer average 19.5/device2021-11: 0 reports for this device; peer average 12.5/device2021-12: 0 reports for this device; peer average 13.5/device2022-01: 0 reports for this device; peer average 6.25/device2022-02: 0 reports for this device; peer average 6.5/device2022-03: 0 reports for this device; peer average 17.5/device2022-04: 0 reports for this device; peer average 23/device2022-05: 0 reports for this device; peer average 6.5/device2022-06: 0 reports for this device; peer average 5/device2022-07: 0 reports for this device; peer average 3.67/device2022-08: 0 reports for this device; peer average 8.33/device2022-09: 0 reports for this device; peer average 14.5/device2022-10: 0 reports for this device; peer average 5.25/device2022-11: 0 reports for this device; peer average 21/device2022-12: 0 reports for this device; peer average 6.33/device2023-01: 0 reports for this device; peer average 11/device2023-02: 0 reports for this device; peer average 20/device2023-03: 0 reports for this device; peer average 20.57/device2023-04: 0 reports for this device; peer average 15.57/device2023-05: 0 reports for this device; peer average 14.2/device2023-06: 0 reports for this device; peer average 10.29/device2023-07: 0 reports for this device; peer average 7/device2023-08: 0 reports for this device; peer average 13.33/device2023-09: 0 reports for this device; peer average 7/device2023-10: 0 reports for this device; peer average 9.75/device2023-11: 0 reports for this device; peer average 12.71/device2023-12: 0 reports for this device; peer average 5.57/device2024-01: 0 reports for this device; peer average 8.8/device2024-02: 0 reports for this device; peer average 16.14/device2024-03: 0 reports for this device; peer average 9.71/device2024-04: 0 reports for this device; peer average 11.67/device2024-05: 0 reports for this device; peer average 13.25/device2024-06: 0 reports for this device; peer average 9.83/device2024-07: 0 reports for this device; peer average 11.29/device2024-08: 0 reports for this device; peer average 8/device2024-09: 0 reports for this device; peer average 15.25/device2024-10: 0 reports for this device; peer average 21.25/device2024-11: 0 reports for this device; peer average 16/device2024-12: 0 reports for this device; peer average 7/device2025-01: 0 reports for this device; peer average 10.2/device2025-02: 0 reports for this device; peer average 3.25/device2025-03: 0 reports for this device; peer average 7.63/device2025-04: 0 reports for this device; peer average 7.25/device2025-05: 0 reports for this device; peer average 6.89/device2025-06: 0 reports for this device; peer average 11.75/device2025-07: 0 reports for this device; peer average 12/device2025-08: 0 reports for this device; peer average 6.13/device2025-09: 0 reports for this device; peer average 3.57/device2025-10: 0 reports for this device; peer average 6.4/device2025-11: 0 reports for this device; peer average 7.33/device2025-12: 0 reports for this device; peer average 7.6/device2026-01: 0 reports for this device; peer average 5.33/device2026-02: 0 reports for this device; peer average 4.67/device2026-03: 0 reports for this device; peer average 10.6/device2026-04: 0 reports for this device; peer average 9.57/device2026-05: 0 reports for this device; peer average 6.5/device2026-06: 0 reports for this device; peer average 6.38/device020304050607080910111201020304050708091011120103040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0204.33
2019-0302
2019-0401.5
2019-0502
2019-0603.5
2019-0703.33
2019-0804
2019-0901.5
2019-1003
2019-11013
2019-1201
2020-0103.6
2020-0201
2020-0301.5
2020-0402.33
2020-0501.5
2020-0702
2020-0803
2020-0901
2020-1004
2020-1103
2020-1204
2021-0101
2021-0304
2021-0405
2021-0503
2021-0604
2021-0703
2021-08013
2021-09025.5
2021-10019.5
2021-11012.5
2021-12013.5
2022-0106.25
2022-0206.5
2022-03017.5
2022-04023
2022-0506.5
2022-0605
2022-0703.67
2022-0808.33
2022-09014.5
2022-1005.25
2022-11021
2022-1206.33
2023-01011
2023-02020
2023-03020.57
2023-04015.57
2023-05014.2
2023-06010.29
2023-0707
2023-08013.33
2023-0907
2023-1009.75
2023-11012.71
2023-1205.57
2024-0108.8
2024-02016.14
2024-0309.71
2024-04011.67
2024-05013.25
2024-0609.83
2024-07011.29
2024-0808
2024-09015.25
2024-10021.25
2024-11016
2024-1207
2025-01010.2
2025-0203.25
2025-0307.63
2025-0407.25
2025-0506.89
2025-06011.75
2025-07012
2025-0806.13
2025-0903.57
2025-1006.4
2025-1107.33
2025-1207.6
2026-0105.33
2026-0204.67
2026-03010.6
2026-0409.57
2026-0506.5
2026-0606.38
This device (reports/month)Average device in BTA (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Zoll Medical Corporation

  • Warning Letter 2026-04-30 ZOLL Medical Corporation
  • Warning Letter 2026-04-30 ZOLL Medical Corporation
  • Warning Letter 2011-04-22 ZOLL Medical Corporation
  • Warning Letter 2011-04-22 ZOLL Medical Corporation
  • Warning Letter 2010-09-30 ZOLL Medical Corporation
  • Warning Letter 2010-09-30 ZOLL Medical Corporation
  • Warning Letter 2010-02-05 Zoll Medical Corporation
  • Warning Letter 2010-02-05 Zoll Medical Corporation
  • VAI 2025-07-24 ZOLL Medical Corporation · 0 citations
  • VAI 2025-07-24 ZOLL Medical Corporation · 0 citations
  • OAI 2025-04-15 ZOLL Medical Corporation · 5 citations
  • OAI 2025-04-15 ZOLL Medical Corporation · 5 citations
  • VAI 2024-02-13 ZOLL Circulation, Inc. · 0 citations
  • VAI 2024-02-13 ZOLL Circulation, Inc. · 0 citations
  • VAI 2022-06-13 Zoll Medical Corporation · 5 citations
  • VAI 2022-06-13 Zoll Medical Corporation · 5 citations
  • NAI 2022-04-08 Vyaire Medical, Inc. · 0 citations
  • VAI 2022-03-10 ZOLL Medical Corporation · 4 citations
  • VAI 2022-03-10 ZOLL Medical Corporation · 4 citations
  • VAI 2017-11-09 ZOLL Circulation, Inc. · 3 citations
  • VAI 2017-10-25 ZOLL Medical Corporation · 5 citations
  • VAI 2017-10-25 ZOLL Medical Corporation · 5 citations
  • NAI 2017-05-05 Vyaire Medical, Inc. · 0 citations
  • VAI 2016-10-18 ZOLL Medical Corporation · 0 citations
  • VAI 2016-10-18 ZOLL Medical Corporation · 0 citations
  • NAI 2016-08-26 ZOLL Medical Corporation · 0 citations
  • NAI 2016-08-26 ZOLL Medical Corporation · 0 citations
  • NAI 2016-04-08 ZOLL Medical Corporation · 0 citations