Clinipad Corp.: FDA clearances and approvals
Clinipad Corp. has 16 FDA 510(k) clearances (first 1980, latest 1994), across 11 product codes in 5 review panels. Median 510(k) review time: 90 days.
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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | 4 | 4 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| KMF | Bandage, Liquid | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| EPE | Brush, Cleaning, Tracheal Tube | 1 | 1 |
| JOH | Tube Tracheostomy And Tube Cuff | 1 | 1 |
| KDD | Kit, Surgical Instrument, Disposable | 1 | 1 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 1 | 1 |
| KNW | Instrument, Biopsy | 1 | 1 |
| KOD | Catheter, Urological | 1 | 1 |
Plus 1 more product codes.
Review panels
- General Hospital (7)
- General and Plastic Surgery (4)
- Anesthesiology (2)
- Gastroenterology and Urology (2)
- Cardiovascular (1)
Most recent Clinipad Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931560 | CARDIAC CATHETERIZATION TRAY | DQO | 1994-07-11 | 468 |
| K931668 | PICC INSERTION TRAY | FOZ | 1994-03-07 | 335 |
| K932071 | I.V. START KIT | FOZ | 1994-02-17 | 295 |
| K932010 | V.A.D. ACCESS KIT | LJT | 1994-02-03 | 286 |
| K932036 | LACERATION TRAY | FRG | 1993-12-13 | 230 |
| K932016 | TRACHEOSTOMY CARE TRAY | JOH | 1993-11-03 | 194 |
| K862562 | PUNCH BIOPSY KIT | KNW | 1986-10-07 | 96 |
| K862563 | TRACHEOSTOMY CLEANSING SOLUTION | EPE | 1986-07-15 | 12 |
| K833075 | WET DRESSING KIT | KDD | 1984-01-27 | 140 |
| K833432 | CATHETER INSERTION KIT | KOD | 1983-12-28 | 84 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Clinipad Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Clinipad Corp. have?
Clinipad Corp. has 16 FDA 510(k) clearances (first 1980, latest 1994), across 11 product codes in 5 review panels.
How long does FDA take to clear Clinipad Corp.'s 510(k)s?
The median time from FDA receipt to decision across Clinipad Corp.'s cleared 510(k)s is 90 days.
What devices does Clinipad Corp. make?
Its most frequent FDA product codes are FRG (Wrap, Sterilization, 4); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 2); KMF (Bandage, Liquid, 2).
Has Clinipad Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Clinipad Corp. Related entities may recall under other names.
Next steps
- See all 16 Clinipad Corp. clearances with predicates and recalls
- Run predicate analysis for product code FRG, Clinipad Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.