Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Preemicare Corp. — Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

163 daysmedian FDA review time
357 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K911450INFANT VENTILATORPreemicare Corp.1991-06-18850
K896375PREEMICARE NEBUTECH NEBULIZER SYSTEMPreemicare Corp.1990-10-293570
K900735MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATORPreemicare Corp.1990-05-02750
K893622PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.Preemicare Corp.1990-01-032370
K893624PREEMICARE MODEL 2500 TRANSPORT WARMERPreemicare Corp.1989-09-271390
K891674NEONATAL ENVIRONMENTAL MONITOR, MODEL 275Preemicare Corp.1989-08-311630
K885350PREEMICARE SERIES 2000 INFANT WARMERPreemicare Corp.1989-08-072220
K884133PREEMICARE SERIES 4000 PHOTOTHERAPY LAMPPreemicare Corp.1989-03-081590
K881476PREEMICARE MODEL D1-X1, SERIES 3000Preemicare Corp.1988-12-082450

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