Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kapp Surgical Instrument, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
358 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200289 | Michler-Kapp Cardiovascular Vent Catheter | Kapp Surgical Instrument, Inc. | 2021-01-28 | 358 | 0 |
| K072216 | KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 | Kapp Surgical Instrument, Inc. | 2007-11-09 | 92 | 1 |
| K050384 | KAPP BARI-RING, MODEL KS-BR-2005 | Kapp Surgical Instrument, Inc. | 2006-01-13 | 332 | 0 |
| K050655 | MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 | Kapp Surgical Instrument, Inc. | 2005-08-08 | 147 | 0 |
| K050657 | MONDEAL CONTOUR HO SYSTEM | Kapp Surgical Instrument, Inc. | 2005-08-08 | 147 | 0 |
| K033930 | KAPP CUSTOM ULNAR HEAD WRIST IMPLANT | Kapp Surgical Instrument, Inc. | 2004-07-28 | 223 | 0 |
| K030237 | KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT | Kapp Surgical Instrument, Inc. | 2003-08-29 | 218 | 0 |
| K844177 | COSGROVE MITRAL VALVE RETRACTOR | Kapp Surgical Instrument, Inc. | 1984-11-08 | 14 | 0 |
| K843368 | KAPP SPINAL BUTTON | Kapp Surgical Instrument, Inc. | 1984-09-12 | 15 | 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