Kit Pak, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Kit Pak, Inc.” (first 1989, latest 1995), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 236 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 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNY | Accessories, Catheter, G-U | 2 | 2 |
| KOD | Catheter, Urological | 2 | 2 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| EYN | Tray, Irrigation, Sterile | 1 | 1 |
| EYQ | Garment, Protective, For Incontinence | 1 | 1 |
| EYT | Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile | 1 | 1 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
| LRO | General Surgery Tray | 1 | 1 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
Plus 1 more product codes.
Review panels
- Gastroenterology and Urology (6)
- General and Plastic Surgery (5)
- Anesthesiology (1)
- General Hospital (1)
Most recent Kit Pak, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942959 | KIT PAK WET SALINE DRESSING | FRO | 1995-02-14 | 236 |
| K941499 | KIT PAK DRESSING CHANGE TRAY | KGX | 1994-07-20 | 113 |
| K932310 | KIT PAK INCONTINENT SKIN CARE KIT | EYQ | 1994-06-01 | 386 |
| K934080 | URINARY DRAINAGE BAG | EYT | 1994-05-18 | 271 |
| K931013 | FOLEY CATHETER TRAY | KNY | 1993-08-09 | 164 |
| K923905 | WOUND DRESSING KIT | MCY | 1993-07-02 | 332 |
| K924051 | KIT PAK I.V. START KIT | LYY | 1993-06-22 | 314 |
| K923906 | FOLEY INSERTION TRAY | KOD | 1993-06-22 | 322 |
| K922051 | KIT PAK'S FLUSHING KIT | KOD | 1993-06-17 | 412 |
| K925281 | KIT PAK URINARY CARE SUPPLIES | KNY | 1993-04-19 | 181 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kit Pak, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Kit Pak, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Kit Pak, Inc.” (first 1989, latest 1995), across 11 product codes in 4 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 Kit Pak, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kit Pak, Inc. is 236 days.
Which FDA product codes appear under Kit Pak, Inc.?
The most frequent FDA product codes under this applicant name are KNY (Accessories, Catheter, G-U, 2); KOD (Catheter, Urological, 2); BSY (Catheters, Suction, Tracheobronchial, 1).
Next steps
- See all 13 Kit Pak, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNY, Kit Pak, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.