Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FFP · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
182 daysmedian FDA review time
325 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964634 | ANOKRYO | Mk Conquest Intl., Inc. | 1997-06-06 | 199 | 0 |
| K901426 | COLONIC BALLOON DILATOR | Telemed Systems, Inc. | 1990-06-21 | 87 | 0 |
| K894618 | INAMED RHEMO-D (TM) DILATOR | Inamed Development Co. | 1990-01-18 | 182 | 0 |
| K884713 | COLONIC BALLOON DIALATORS | Primrose Medical, Inc. | 1989-09-29 | 325 | 0 |
| K830354 | COLORECTAL DILATOR | Cleveland Medical Supply & Services | 1983-05-27 | 113 | 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