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AED

Model 5727B · NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · DI 00848657006262

EOB — Nasopharyngoscope (Flexible Or Rigid) · Class II · 21 CFR 874.4760

UDILibrary device dossier · generated 2026-09-07 · 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.

132740532019-01: 0 reports for this device; peer average 2.83/device2019-02: 0 reports for this device; peer average 3/device2019-03: 0 reports for this device; peer average 14.25/device2019-04: 0 reports for this device; peer average 53.43/device2019-05: 0 reports for this device; peer average 6.63/device2019-06: 0 reports for this device; peer average 4.67/device2019-07: 0 reports for this device; peer average 3.5/device2019-08: 0 reports for this device; peer average 5.54/device2019-09: 0 reports for this device; peer average 5.8/device2019-10: 0 reports for this device; peer average 7/device2019-11: 0 reports for this device; peer average 7/device2019-12: 0 reports for this device; peer average 6.33/device2020-01: 0 reports for this device; peer average 6.33/device2020-02: 0 reports for this device; peer average 10.8/device2020-03: 0 reports for this device; peer average 4.22/device2020-04: 0 reports for this device; peer average 5.27/device2020-05: 0 reports for this device; peer average 3.64/device2020-06: 0 reports for this device; peer average 5.7/device2020-07: 0 reports for this device; peer average 5/device2020-08: 0 reports for this device; peer average 5.69/device2020-09: 0 reports for this device; peer average 6.38/device2020-10: 0 reports for this device; peer average 10.27/device2020-11: 0 reports for this device; peer average 7.31/device2020-12: 0 reports for this device; peer average 10.17/device2021-01: 0 reports for this device; peer average 5.64/device2021-02: 0 reports for this device; peer average 5.86/device2021-03: 0 reports for this device; peer average 10.55/device2021-04: 0 reports for this device; peer average 5.96/device2021-05: 0 reports for this device; peer average 7.72/device2021-06: 0 reports for this device; peer average 6.05/device2021-07: 0 reports for this device; peer average 4.7/device2021-08: 0 reports for this device; peer average 6.72/device2021-09: 0 reports for this device; peer average 6.47/device2021-10: 0 reports for this device; peer average 7.81/device2021-11: 0 reports for this device; peer average 5.74/device2021-12: 0 reports for this device; peer average 6.29/device2022-01: 0 reports for this device; peer average 8.5/device2022-02: 0 reports for this device; peer average 6.96/device2022-03: 0 reports for this device; peer average 8.36/device2022-04: 0 reports for this device; peer average 9/device2022-05: 0 reports for this device; peer average 6.73/device2022-06: 0 reports for this device; peer average 9.45/device2022-07: 0 reports for this device; peer average 9.23/device2022-08: 0 reports for this device; peer average 8.75/device2022-09: 0 reports for this device; peer average 9.32/device2022-10: 0 reports for this device; peer average 8.03/device2022-11: 0 reports for this device; peer average 7.12/device2022-12: 0 reports for this device; peer average 7.41/device2023-01: 0 reports for this device; peer average 7.48/device2023-02: 0 reports for this device; peer average 6.83/device2023-03: 0 reports for this device; peer average 9.53/device2023-04: 0 reports for this device; peer average 8.23/device2023-05: 0 reports for this device; peer average 6.31/device2023-06: 0 reports for this device; peer average 6.66/device2023-07: 0 reports for this device; peer average 6.97/device2023-08: 0 reports for this device; peer average 10.67/device2023-09: 0 reports for this device; peer average 9.46/device2023-10: 0 reports for this device; peer average 9.02/device2023-11: 0 reports for this device; peer average 11.81/device2023-12: 0 reports for this device; peer average 8.44/device2024-01: 0 reports for this device; peer average 6.41/device2024-02: 0 reports for this device; peer average 10.62/device2024-03: 0 reports for this device; peer average 8.55/device2024-04: 0 reports for this device; peer average 8.87/device2024-05: 0 reports for this device; peer average 7.8/device2024-06: 0 reports for this device; peer average 9.02/device2024-07: 0 reports for this device; peer average 9.5/device2024-08: 0 reports for this device; peer average 9.6/device2024-09: 0 reports for this device; peer average 8.71/device2024-10: 0 reports for this device; peer average 8.9/device2024-11: 0 reports for this device; peer average 8.3/device2024-12: 0 reports for this device; peer average 4.47/device2025-01: 0 reports for this device; peer average 4.2/device2025-02: 0 reports for this device; peer average 3.55/device2025-03: 0 reports for this device; peer average 4.38/device2025-04: 0 reports for this device; peer average 5.88/device2025-05: 0 reports for this device; peer average 4.26/device2025-06: 0 reports for this device; peer average 5.18/device2025-07: 0 reports for this device; peer average 6.55/device2025-08: 0 reports for this device; peer average 4.08/device2025-09: 0 reports for this device; peer average 3.74/device2025-10: 0 reports for this device; peer average 4.5/device2025-11: 0 reports for this device; peer average 4.8/device2025-12: 0 reports for this device; peer average 4.47/device2026-01: 0 reports for this device; peer average 4.09/device2026-02: 0 reports for this device; peer average 5.1/device2026-03: 0 reports for this device; peer average 4.15/device2026-04: 0 reports for this device; peer average 6.64/device2026-05: 0 reports for this device; peer average 6.43/device2026-06: 0 reports for this device; peer average 5.02/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.83
2019-0203
2019-03014.25
2019-04053.43
2019-0506.63
2019-0604.67
2019-0703.5
2019-0805.54
2019-0905.8
2019-1007
2019-1107
2019-1206.33
2020-0106.33
2020-02010.8
2020-0304.22
2020-0405.27
2020-0503.64
2020-0605.7
2020-0705
2020-0805.69
2020-0906.38
2020-10010.27
2020-1107.31
2020-12010.17
2021-0105.64
2021-0205.86
2021-03010.55
2021-0405.96
2021-0507.72
2021-0606.05
2021-0704.7
2021-0806.72
2021-0906.47
2021-1007.81
2021-1105.74
2021-1206.29
2022-0108.5
2022-0206.96
2022-0308.36
2022-0409
2022-0506.73
2022-0609.45
2022-0709.23
2022-0808.75
2022-0909.32
2022-1008.03
2022-1107.12
2022-1207.41
2023-0107.48
2023-0206.83
2023-0309.53
2023-0408.23
2023-0506.31
2023-0606.66
2023-0706.97
2023-08010.67
2023-0909.46
2023-1009.02
2023-11011.81
2023-1208.44
2024-0106.41
2024-02010.62
2024-0308.55
2024-0408.87
2024-0507.8
2024-0609.02
2024-0709.5
2024-0809.6
2024-0908.71
2024-1008.9
2024-1108.3
2024-1204.47
2025-0104.2
2025-0203.55
2025-0304.38
2025-0405.88
2025-0504.26
2025-0605.18
2025-0706.55
2025-0804.08
2025-0903.74
2025-1004.5
2025-1104.8
2025-1204.47
2026-0104.09
2026-0205.1
2026-0304.15
2026-0406.64
2026-0506.43
2026-0605.02
This device (reports/month)Average device in EOB (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K170285 — cited as predicate by K170825, K200657, K233850, K251628, K252161, K253845

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

Manufacturer compliance record — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

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  • VAI 2019-08-30 National Advanced Endoscopy Devices Inc · 1 citations
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  • VAI 2015-10-26 National Advanced Endoscopy Devices Inc · 3 citations
  • VAI 2015-10-26 National Advanced Endoscopy Devices Inc · 3 citations
  • NAI 2012-07-17 National Advanced Endoscopy Devices Inc · 0 citations
  • NAI 2012-07-17 National Advanced Endoscopy Devices Inc · 0 citations