Currie Medical Specialties, Inc.: FDA clearances and approvals
Currie Medical Specialties, Inc. has 13 FDA 510(k) clearances (first 1983, latest 2015), across 9 product codes in 4 review panels. Median 510(k) review time: 55 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 92 |
| 2015 | 2 | 142 |
| 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 | 4 | 4 |
| KKX | Drape, Surgical, Antimicrobial | 2 | 2 |
| BZA | Connector, Airway (Extension) | 1 | 1 |
| CBT | Arterial Blood Sampling Kit | 1 | 1 |
| FMC | Patient Examination Glove | 1 | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
| KDD | Kit, Surgical Instrument, Disposable | 1 | 1 |
| LRO | General Surgery Tray | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Currie Medical Specialties, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151158 | ALP VasQcare Take Home System | JOW | 2015-12-10 | 223 |
| K143317 | Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) | JOW | 2015-01-20 | 62 |
| K140092 | CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES) | JOW | 2014-04-16 | 92 |
| K112311 | ALP 501 RB PUMP SYSTEM | JOW | 2011-09-01 | 21 |
| K902441 | DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS) | KDD | 1990-08-23 | 83 |
| K874760 | CK 4900 SERIES, GOWN AND TOWEL PAK | LRO | 1987-12-10 | 21 |
| K872395 | CK 1600 SERIES, TOWELS | KKX | 1987-07-02 | 10 |
| K871737 | CK 7000 SERIES 5 IN 1 CONNECTOR AND Y-CONNECTOR | BZA | 1987-06-22 | 48 |
| K864816 | CK 5000 SERIES, ACE BANDAGE/ESMARK BANDAGE | — | 1987-01-08 | 30 |
| K864697 | CK 6000 SERIES, TOWELS | KKX | 1986-12-18 | 16 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Currie Medical Specialties, Inc..
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 Currie Medical Specialties, Inc. have?
Currie Medical Specialties, Inc. has 13 FDA 510(k) clearances (first 1983, latest 2015), across 9 product codes in 4 review panels.
How long does FDA take to clear Currie Medical Specialties, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Currie Medical Specialties, Inc.'s cleared 510(k)s is 55 days.
What devices does Currie Medical Specialties, Inc. make?
Its most frequent FDA product codes are JOW (Sleeve, Limb, Compressible, 4); KKX (Drape, Surgical, Antimicrobial, 2); BZA (Connector, Airway (Extension), 1).
Has Currie Medical Specialties, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Currie Medical Specialties, Inc. Related entities may recall under other names.
Next steps
- See all 13 Currie Medical Specialties, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOW, Currie Medical Specialties, Inc.'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.