Clearmedical, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Clearmedical, Inc.” (first 2002, latest 2005), across 8 product codes in 5 review panels. Median 510(k) review time under this name: 217 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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | 5 | 5 |
| NLF | Oximeter, Reprocessed | 3 | 3 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| KBG | Trocar, Sinus | 1 | 1 |
| NLL | Staple, Implantable, Reprocessed | 1 | 1 |
| NLU | Forceps, Biopsy, Electric, Reprocessed | 1 | 1 |
| NMJ | Clip, Implantable, Reprocessed | 1 | 1 |
Review panels
- Cardiovascular (6)
- Anesthesiology (3)
- General and Plastic Surgery (3)
- Ear, Nose and Throat (1)
- Gastroenterology and Urology (1)
Most recent Clearmedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033579 | REPROCESSED MULTIPLE CLIP APPLIERS | NMJ | 2005-07-11 | 606 |
| K033578 | REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS | NLL | 2005-07-11 | 606 |
| K033591 | REPROCESSED TROCARS | KBG | 2005-06-03 | 568 |
| K033592 | REPROCESSED SURGICAL SCISSORS AND GRASPERS | GEI | 2004-07-27 | 257 |
| K033593 | REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS | NLU | 2003-11-20 | 7 |
| K031416 | CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF | DXQ | 2003-07-15 | 71 |
| K012622 | CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 | NLF | 2002-07-03 | 324 |
| K012609 | CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25 | NLF | 2002-07-03 | 324 |
| K012600 | CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L | NLF | 2002-07-03 | 324 |
| K012621 | CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT | JOW | 2002-02-06 | 177 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Clearmedical, 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 Clearmedical, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Clearmedical, Inc.” (first 2002, latest 2005), across 8 product codes in 5 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 Clearmedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clearmedical, Inc. is 217 days.
Which FDA product codes appear under Clearmedical, Inc.?
The most frequent FDA product codes under this applicant name are JOW (Sleeve, Limb, Compressible, 5); NLF (Oximeter, Reprocessed, 3); DXQ (Blood Pressure Cuff, 1).
Next steps
- See all 14 Clearmedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOW, Clearmedical, 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.