Pedicraft, Inc.: FDA clearances and approvals
Pedicraft, Inc. has 5 FDA 510(k) clearances (first 1982, latest 1993), across 2 product codes in 1 review panel. Median 510(k) review time: 89 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 |
|---|---|---|---|
| FMS | Bed, Pediatric Open Hospital | 3 | 3 |
| FRP | Holder, Infant Position | 2 | 2 |
Review panels
- General Hospital (5)
Most recent Pedicraft, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925949 | PEDICRAGT BASSINET | FMS | 1993-04-20 | 147 |
| K925817 | HEAD & FOOT END DROP PEDI-CRIB | FMS | 1993-04-20 | 154 |
| K905630 | INFANT REFLUX SLING | FRP | 1991-03-13 | 89 |
| K905629 | PEDICRAFT INFANT REFLUX WEDGE | FRP | 1991-03-13 | 89 |
| K821773 | PEDICRAFT BED, MODEL B2944 | FMS | 1982-06-23 | 7 |
Recalls
openFDA lists no recalls under a recalling firm named Pedicraft, 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 Pedicraft, Inc. have?
Pedicraft, Inc. has 5 FDA 510(k) clearances (first 1982, latest 1993), across 2 product codes in 1 review panel.
How long does FDA take to clear Pedicraft, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Pedicraft, Inc.'s cleared 510(k)s is 89 days.
What devices does Pedicraft, Inc. make?
Its most frequent FDA product codes are FMS (Bed, Pediatric Open Hospital, 3); FRP (Holder, Infant Position, 2).
Has Pedicraft, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Pedicraft, Inc. Related entities may recall under other names.
Next steps
- See all 5 Pedicraft, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMS, Pedicraft, 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.