Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kit Pak, Inc. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
236 daysmedian FDA review time
386 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K942959 | KIT PAK WET SALINE DRESSING | Kit Pak, Inc. | 1995-02-14 | 236 | 0 |
| K941499 | KIT PAK DRESSING CHANGE TRAY | Kit Pak, Inc. | 1994-07-20 | 113 | 0 |
| K932310 | KIT PAK INCONTINENT SKIN CARE KIT | Kit Pak, Inc. | 1994-06-01 | 386 | 0 |
| K934080 | URINARY DRAINAGE BAG | Kit Pak, Inc. | 1994-05-18 | 271 | 0 |
| K931013 | FOLEY CATHETER TRAY | Kit Pak, Inc. | 1993-08-09 | 164 | 0 |
| K923905 | WOUND DRESSING KIT | Kit Pak, Inc. | 1993-07-02 | 332 | 0 |
| K924051 | KIT PAK I.V. START KIT | Kit Pak, Inc. | 1993-06-22 | 314 | 0 |
| K923906 | FOLEY INSERTION TRAY | Kit Pak, Inc. | 1993-06-22 | 322 | 0 |
| K922051 | KIT PAK'S FLUSHING KIT | Kit Pak, Inc. | 1993-06-17 | 412 | 0 |
| K925281 | KIT PAK URINARY CARE SUPPLIES | Kit Pak, Inc. | 1993-04-19 | 181 | 0 |
| K900148 | KIT PAK IRRIGATION TRAY | Kit Pak, Inc. | 1990-04-23 | 102 | 0 |
| K890570 | SKIN SCRUB KIT | Kit Pak, Inc. | 1989-05-05 | 88 | 0 |
| K885131 | KIT PAK SUCTION CATHETER KIT | Kit Pak, Inc. | 1989-01-09 | 28 | 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