Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Endoscopy, Inc. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
121 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853274 | AMERICAN DILATATION SYSTEM | American Endoscopy, Inc. | 1985-10-17 | 73 | 0 |
| K841384 | PROXIMA 1 PH MONITOR | American Endoscopy, Inc. | 1984-07-19 | 121 | 0 |
| K833491 | ENDO BITE BLOCK | American Endoscopy, Inc. | 1984-04-25 | 201 | 0 |
| K840818 | BIOPSY FORCEPS | American Endoscopy, Inc. | 1984-04-13 | 49 | 0 |
| K833859 | TAMPONADE BALLOON CUFF | American Endoscopy, Inc. | 1984-01-03 | 57 | 0 |
| K833492 | PERCUTANEOUS ENDOSCOPIC GASTROSCOPY | American Endoscopy, Inc. | 1983-11-29 | 53 | 0 |
| K832458 | AUTOMATIC ENDOSCOPE | American Endoscopy, Inc. | 1983-10-20 | 86 | 2 |
| K821818 | RETRIEVAL BALLOONS | American Endoscopy, Inc. | 1982-09-24 | 95 | 0 |
| K821819 | PIGTAIL STENTS | American Endoscopy, Inc. | 1982-08-20 | 60 | 0 |
| K822062 | BALL TIP COAGULATING ELECTRODES | American Endoscopy, Inc. | 1982-08-19 | 37 | 0 |
| K821817 | PIGTAIL NASAL CATHETERS | American Endoscopy, Inc. | 1982-08-10 | 50 | 0 |
| K822061 | LAVAGING CATHETERS | American Endoscopy, Inc. | 1982-07-20 | 7 | 0 |
| K821697 | INJECTION ASPIRATING NEEDLES | American Endoscopy, Inc. | 1982-06-25 | 17 | 0 |
| K820431 | E.R.C.P. CANNULAS | American Endoscopy, Inc. | 1982-04-09 | 51 | 0 |
| K820429 | SPIRAL STONE AND RETRIEVAL BASKETS | American Endoscopy, Inc. | 1982-04-08 | 50 | 0 |
| K820430 | DIATHERMIC SNARES | American Endoscopy, Inc. | 1982-04-08 | 50 | 0 |
| K820240 | PAPILLOTOMES | American Endoscopy, Inc. | 1982-03-26 | 56 | 0 |
| K820239 | RETRIEVAL FORCEPS | American Endoscopy, Inc. | 1982-03-26 | 56 | 0 |
| K820259 | STERILE CYTOLOGY BRUSHES | American Endoscopy, Inc. | 1982-03-05 | 32 | 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