Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Cranbury Medical Labs, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
80 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K828586 | ENTREKIN MODEL DX-300 CONTINUOUS WAVE ULTRASONIC DOPPLER TRA | Cranbury Medical Labs, Inc. | 1982-12-14 | 21 | 0 |
| K822830 | MEDICAL LABS FETAL SCAN #1000 W/CENTRAL | Cranbury Medical Labs, Inc. | 1982-09-30 | 9 | 0 |
| K827718 | UNKNOWN | Cranbury Medical Labs, Inc. | 1982-08-16 | 55 | 0 |
| K827375 | BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 2000 AND 2000A | Cranbury Medical Labs, Inc. | 1982-07-02 | 80 | 0 |
| K827376 | BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 800 | Cranbury Medical Labs, Inc. | 1982-07-02 | 80 | 0 |
| K813457 | FETASCAN 2000,2000A OBSTETRICAL DATA | Cranbury Medical Labs, Inc. | 1982-02-12 | 64 | 0 |
| K813458 | FETASCAN 1000, 1000A OBSTETRICAL DATA | Cranbury Medical Labs, Inc. | 1982-01-28 | 49 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda