Atlas FDA

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

Commercial Products & Engineering Co. — Predicate Candidate Screening

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

22 daysmedian FDA review time
80 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K894891IRRIGATOR STANDCommercial Products & Engineering Co.1989-08-23220
K884542SIC 3999 FOLDING ADJUSTABLE HOSPITAL BEDCommercial Products & Engineering Co.1988-11-21210
K883463HOSPITAL BED CLOTHING CRADLECommercial Products & Engineering Co.1988-09-19350
K882333FLOOR LIGHTCommercial Products & Engineering Co.1988-06-23170
K873545PORTABLE FIELD DENTAL OPERATING & TREATMENT UNITCommercial Products & Engineering Co.1987-11-20800

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