Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GCP — Predicate Candidate Screening
13 FDA 510(k) clearances under this product code; the 50 most recent screened below.
61 daysmedian FDA review time
122 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954614 | EOS BRAND DISPOSABLE PROCTOSCOPE | North Eos Industries, Inc. | 1996-04-10 | 188 | 0 |
| K896505 | PORGES UNIVERSAL HANDLES | Porges Corp. | 1990-01-30 | 76 | 0 |
| K896008 | MODEL 6500 MERCURY ARC LIGHT SOURCE | Medical Dynamics, Inc. | 1989-12-27 | 75 | 0 |
| K862424 | STEERABLE CATHETER SYSTEM | Endovations | 1986-09-22 | 88 | 0 |
| K860103 | MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE | Endotherapeutics | 1986-02-12 | 33 | 0 |
| K843683 | MODULAR FIBERSCOPE SYSTEM | Reichert Scientific Instruments | 1985-01-18 | 122 | 0 |
| K833859 | TAMPONADE BALLOON CUFF | American Endoscopy, Inc. | 1984-01-03 | 57 | 0 |
| K821999 | ENDOSCOPIC SCLEROTHERAPY BALLOON | Retech | 1982-08-27 | 51 | 0 |
| K801247 | CCD ENDOSCOPE AND ATTACHMENTS | Welch Allyn, Inc. | 1980-07-28 | 61 | 0 |
| K790071 | ENDOSCOPE AND ACCESSORIES | Olympus Corp. | 1979-04-02 | 81 | 4 |
| K771919 | FIBER OPTICS SIGMOIDOSCOPE | Propper Mfg. Co., Inc. | 1977-10-20 | 8 | 0 |
| K771920 | FIBER OPTICS PROCTOSCOPE | Propper Mfg. Co., Inc. | 1977-10-20 | 8 | 0 |
| K771918 | FIBEO OPTICS ILLUM. SYSTEM | Propper Mfg. Co., Inc. | 1977-10-20 | 8 | 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