Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medi-Flex Hospital Products, Inc. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
93 daysmedian FDA review time
586 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970441 | K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH | Medi-Flex Hospital Products, Inc. | 1997-05-09 | 93 | 0 |
| K962740 | DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641 | Medi-Flex Hospital Products, Inc. | 1996-09-06 | 53 | 0 |
| K952201 | PORT-A-CATH ACCESS KIT | Medi-Flex Hospital Products, Inc. | 1995-10-04 | 147 | 0 |
| K952416 | TRACHEOSTOMY CARE KIT | Medi-Flex Hospital Products, Inc. | 1995-08-09 | 78 | 0 |
| K952256 | PICC LINE KIT | Medi-Flex Hospital Products, Inc. | 1995-07-31 | 77 | 0 |
| K952007 | ADHEROL SEPP APPLICATOR | Medi-Flex Hospital Products, Inc. | 1995-06-08 | 41 | 0 |
| K934790 | SEPP ADHESIVE REMOVER | Medi-Flex Hospital Products, Inc. | 1994-03-11 | 157 | 0 |
| K920399 | COMPOUND BENZOIN TINCTURE USP FREPP | Medi-Flex Hospital Products, Inc. | 1994-01-25 | 726 | 0 |
| K923516 | COMPOUND BENZOIN TINCTURE USP SEPP | Medi-Flex Hospital Products, Inc. | 1994-01-25 | 586 | 0 |
| K930196 | CEPTI-SEAL I.V. PREP KIT | Medi-Flex Hospital Products, Inc. | 1993-07-02 | 169 | 0 |
| K921347 | CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER | Medi-Flex Hospital Products, Inc. | 1993-01-08 | 296 | 0 |
| K920398 | CEPTI-SEAL DRESSING CHNG. KIT FOR CENT. VENOUS CAT | Medi-Flex Hospital Products, Inc. | 1992-04-15 | 76 | 0 |
| K914316 | CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH | Medi-Flex Hospital Products, Inc. | 1991-12-24 | 89 | 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