Medi-Flex Hospital Products, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Medi-Flex Hospital Products, Inc.” (first 1991, latest 1997), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 93 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | 3 | 3 |
| FMF | Syringe, Piston | 2 | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| FPX | Strip, Adhesive, Closure, Skin | 1 | 1 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| KOX | Solvent, Adhesive Tape | 1 | 1 |
| LRS | I.V. Start Kit | 1 | 1 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
| MCY | Wound Dressing Kit | 1 | 1 |
Review panels
Most recent Medi-Flex Hospital Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970441 | K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH | FPX | 1997-05-09 | 93 |
| K962740 | DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641 | KMF | 1996-09-06 | 53 |
| K952201 | PORT-A-CATH ACCESS KIT | FMF | 1995-10-04 | 147 |
| K952416 | TRACHEOSTOMY CARE KIT | BTO | 1995-08-09 | 78 |
| K952256 | PICC LINE KIT | FOZ | 1995-07-31 | 77 |
| K952007 | ADHEROL SEPP APPLICATOR | FRO | 1995-06-08 | 41 |
| K934790 | SEPP ADHESIVE REMOVER | KOX | 1994-03-11 | 157 |
| K923516 | COMPOUND BENZOIN TINCTURE USP SEPP | KMF | 1994-01-25 | 586 |
| K920399 | COMPOUND BENZOIN TINCTURE USP FREPP | KMF | 1994-01-25 | 726 |
| K930196 | CEPTI-SEAL I.V. PREP KIT | LRS | 1993-07-02 | 169 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medi-Flex Hospital Products, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medi-Tech, Inc. (36 510(k)s)
- Medi-Globe Corp. (25 510(k)s)
- Medi-Plast Intl., Inc. (12 510(k)s)
- The Medi-Dose Group (10 510(k)s)
- Medi-Craft , Ltd. (9 510(k)s)
- Medi Nuclear Corp., Inc. (9 510(k)s)
- Medi-Physics Inc. Dba Nycomed Amersham Imaging (9 510(k)s)
- Medi-Spec (8 510(k)s)
- Medi-Dose, Inc. (4 510(k)s)
- Medi-Dyne, Inc. (4 510(k)s)
- Medi-Man Rehabilitation Products, Inc. (4 510(k)s)
- Medi-Source, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medi-Flex Hospital Products, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Medi-Flex Hospital Products, Inc.” (first 1991, latest 1997), across 10 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 Medi-Flex Hospital Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medi-Flex Hospital Products, Inc. is 93 days.
Which FDA product codes appear under Medi-Flex Hospital Products, Inc.?
The most frequent FDA product codes under this applicant name are KMF (Bandage, Liquid, 3); FMF (Syringe, Piston, 2); BTO (Tube, Tracheostomy (W/Wo Connector), 1).
Next steps
- See all 13 Medi-Flex Hospital Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KMF, Medi-Flex Hospital Products, 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.