Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
National Advanced Endoscopy Devices, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
212 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170285 | AED Sinuscope | National Advanced Endoscopy Devices, Inc. | 2017-08-01 | 183 | 0 |
| K141515 | AED HYSTEROSCOPE AND ACCESSORIES | National Advanced Endoscopy Devices, Inc. | 2015-01-07 | 212 | 0 |
| K102663 | AED RESECTOSCOPE | National Advanced Endoscopy Devices, Inc. | 2010-12-30 | 106 | 0 |
| K081553 | AED BIPOLAR FORCEPS, MODEL 13-1646 | National Advanced Endoscopy Devices, Inc. | 2008-09-29 | 118 | 0 |
| K081503 | AED MONOPOLAR LAP ACCESSORIES | National Advanced Endoscopy Devices, Inc. | 2008-09-25 | 119 | 0 |
| K993689 | AED CYSTOSCOPE | National Advanced Endoscopy Devices, Inc. | 1999-12-15 | 44 | 0 |
| K993688 | AED LAPAROSCOPE | National Advanced Endoscopy Devices, Inc. | 1999-12-06 | 35 | 0 |
| K991656 | AED ARTHROSCOPE | National Advanced Endoscopy Devices, Inc. | 1999-12-02 | 203 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda