Kapp Surgical Instrument, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Kapp Surgical Instrument, Inc.” (first 1984, latest 2021), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 147 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 358 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kapp Surgical Instrument, Inc. took a median 358 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 2 | 2 |
| NEU | Marker, Radiographic, Implantable | 2 | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| GAD | Retractor | 1 | 1 |
| HTN | Washer, Bolt Nut | 1 | 1 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 1 | 1 |
| KXE | Prosthesis, Wrist, Hemi-, Ulnar | 1 | 1 |
Review panels
Most recent Kapp Surgical Instrument, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200289 | Michler-Kapp Cardiovascular Vent Catheter | DWF | 2021-01-28 | 358 |
| K072216 | KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 | NEU | 2007-11-09 | 92 |
| K050384 | KAPP BARI-RING, MODEL KS-BR-2005 | NEU | 2006-01-13 | 332 |
| K050657 | MONDEAL CONTOUR HO SYSTEM | HRS | 2005-08-08 | 147 |
| K050655 | MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 | HRS | 2005-08-08 | 147 |
| K033930 | KAPP CUSTOM ULNAR HEAD WRIST IMPLANT | KXE | 2004-07-28 | 223 |
| K030237 | KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT | KWI | 2003-08-29 | 218 |
| K844177 | COSGROVE MITRAL VALVE RETRACTOR | GAD | 1984-11-08 | 14 |
| K843368 | KAPP SPINAL BUTTON | HTN | 1984-09-12 | 15 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2011-05-24.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Kapp Surgical Instrument, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Kapp Surgical Instrument, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Kapp Surgical Instrument, Inc.” (first 1984, latest 2021), across 7 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kapp Surgical Instrument, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kapp Surgical Instrument, Inc. is 147 days.
Which FDA product codes appear under Kapp Surgical Instrument, Inc.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 2); NEU (Marker, Radiographic, Implantable, 2); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 1).
Next steps
- See all 9 Kapp Surgical Instrument, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Kapp Surgical Instrument, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.