Carapace, Inc.: FDA clearances and approvals
Carapace, Inc. has 22 FDA 510(k) clearances (first 1979, latest 1994), across 16 product codes in 7 review panels. Median 510(k) review time: 260 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 |
|---|---|---|---|
| LRO | General Surgery Tray | 6 | 6 |
| LGF | Component, Cast | 2 | 2 |
| CAZ | Anesthesia Conduction Kit | 1 | 1 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| FRL | Fiber, Medical, Absorbent | 1 | 1 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 | 1 |
| IRO | Vibrator, Therapeutic | 1 | 1 |
Plus 6 more product codes.
Review panels
- General and Plastic Surgery (9)
- General Hospital (4)
- Orthopedic (3)
- Obstetrics and Gynecology (2)
- Physical Medicine (2)
- Anesthesiology (1)
- Cardiovascular (1)
Most recent Carapace, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931722 | CARAPACE LABOR AND DELIVERY SETS | MLS | 1994-03-23 | 350 |
| K931822 | CARAPACE PELVIC EXAM TRAYS | MLT | 1994-03-07 | 333 |
| K931729 | I.V. START KIT | FOZ | 1994-02-22 | 321 |
| K931820 | CARAPACE STILLWATER BOWL SET | LRO | 1994-02-07 | 305 |
| K931669 | CARAPACE DEBRIDEMENT KITS | FRG | 1994-02-07 | 307 |
| K931760 | CARAPACE PACKING GAUZE TRAYS | LRO | 1994-02-04 | 302 |
| K932653 | SWISSTEK 2000(TM) CAST REMOVAL SYSTEM | LGH | 1994-01-28 | 240 |
| K931819 | CARAPACE SUTURE REMOVAL TRAYS | IRO | 1994-01-26 | 293 |
| K931758 | CARAPACE WOUND DRESSING KITS & LACERATION TRAYS | LRO | 1994-01-26 | 293 |
| K931759 | CARAPACE STERILE GAUZE TRAYS | LRO | 1994-01-25 | 292 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Carapace, 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 Carapace, Inc. have?
Carapace, Inc. has 22 FDA 510(k) clearances (first 1979, latest 1994), across 16 product codes in 7 review panels.
How long does FDA take to clear Carapace, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Carapace, Inc.'s cleared 510(k)s is 260 days.
What devices does Carapace, Inc. make?
Its most frequent FDA product codes are LRO (General Surgery Tray, 6); LGF (Component, Cast, 2); CAZ (Anesthesia Conduction Kit, 1).
Has Carapace, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Carapace, Inc. Related entities may recall under other names.
Next steps
- See all 22 Carapace, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LRO, Carapace, 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.