Cranbury Medical Labs, Inc.: FDA clearances and approvals
Cranbury Medical Labs, Inc. has 7 FDA 510(k) clearances (first 1982, latest 1982), across 2 product codes in 1 review panel. Median 510(k) review time: 55 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 |
|---|---|---|---|
| HGM | System, Monitoring, Perinatal | 3 | 3 |
Plus 1 more product codes.
Review panels
Most recent Cranbury Medical Labs, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K828586 | ENTREKIN MODEL DX-300 CONTINUOUS WAVE ULTRASONIC DOPPLER TRANSDUCER | — | 1982-12-14 | 21 |
| K822830 | MEDICAL LABS FETAL SCAN #1000 W/CENTRAL | HGM | 1982-09-30 | 9 |
| K827718 | UNKNOWN | — | 1982-08-16 | 55 |
| K827376 | BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 800 | — | 1982-07-02 | 80 |
| K827375 | BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 2000 AND 2000A | — | 1982-07-02 | 80 |
| K813457 | FETASCAN 2000,2000A OBSTETRICAL DATA | HGM | 1982-02-12 | 64 |
| K813458 | FETASCAN 1000, 1000A OBSTETRICAL DATA | HGM | 1982-01-28 | 49 |
Recalls
openFDA lists no recalls under a recalling firm named Cranbury Medical Labs, 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 Cranbury Medical Labs, Inc. have?
Cranbury Medical Labs, Inc. has 7 FDA 510(k) clearances (first 1982, latest 1982), across 2 product codes in 1 review panel.
How long does FDA take to clear Cranbury Medical Labs, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cranbury Medical Labs, Inc.'s cleared 510(k)s is 55 days.
What devices does Cranbury Medical Labs, Inc. make?
Its most frequent FDA product codes are HGM (System, Monitoring, Perinatal, 3).
Has Cranbury Medical Labs, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cranbury Medical Labs, Inc. Related entities may recall under other names.
Next steps
- See all 7 Cranbury Medical Labs, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HGM, Cranbury Medical Labs, 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.