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Aspen® Anti-fog Solution

Model DF-3100A · ASPEN SURGICAL PRODUCTS, INC. · DI 00840113200863

OCT — Anti Fog Solution And Accessories, Endoscopy · Class II · 21 CFR 876.1500

UDILibrary device dossier · generated 2026-09-12 · 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.

12232019-02: 0 reports for this device; peer average 2/device2019-12: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1.5/device2024-11: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 1.5/device2025-05: 0 reports for this device; peer average 1.5/device2025-07: 0 reports for this device; peer average 1.5/device2025-08: 0 reports for this device; peer average 1.33/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1.6/device2025-12: 0 reports for this device; peer average 1.67/device2026-03: 0 reports for this device; peer average 3/device2026-05: 0 reports for this device; peer average 3/device021208110811030507080910110102030507080910120305
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0202
2019-1202
2021-0801
2021-1102
2023-0801
2023-1101
2024-0301
2024-0501
2024-0701
2024-0801
2024-0901
2024-1001.5
2024-1101
2025-0101
2025-0201
2025-0301.5
2025-0501.5
2025-0701.5
2025-0801.33
2025-0901
2025-1001.6
2025-1201.67
2026-0303
2026-0503
This device (reports/month)Average device in OCT (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K932449 — cited as predicate by K190864, K231822

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — ASPEN SURGICAL PRODUCTS, INC.

  • VAI 2017-11-08 Aspen Surgical Products, Inc. · 5 citations
  • VAI 2017-11-08 Aspen Surgical Products, Inc. · 5 citations
  • NAI 2017-03-02 Aspen Surgical Products Inc · 0 citations
  • NAI 2015-11-03 Aspen Surgical Puerto Rico Corp. · 0 citations
  • NAI 2015-02-11 Aspen Surgical Products, Inc. · 0 citations
  • NAI 2015-02-11 Aspen Surgical Products, Inc. · 0 citations
  • NAI 2014-07-01 Aspen Surgical Products Inc · 0 citations
  • VAI 2013-02-15 Aspen Surgical Products, Inc. · 1 citations
  • VAI 2013-02-15 Aspen Surgical Products, Inc. · 1 citations
  • NAI 2012-09-28 Aspen Surgical Products Inc · 0 citations
  • VAI 2010-02-26 Aspen Surgical Products, Inc. · 4 citations
  • VAI 2010-02-26 Aspen Surgical Products, Inc. · 4 citations