Atlas FDA

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

Fraser Harlake, Inc. — Predicate Candidate Screening

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

42 daysmedian FDA review time
195 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K841903FRASER HARLAKE EMERG. CARE SUCTION SYSFraser Harlake, Inc.1984-06-14380
K833799SPHYGOMANO METERFraser Harlake, Inc.1984-05-141950
K841496FRASER HARLAKE HOPE III RESUSCITATORFraser Harlake, Inc.1984-04-24140
K833692FRASER HARLAKE DENTAL ANTI-POLUTION SYSFraser Harlake, Inc.1983-11-29420
K833151BOYLE SYSTEM ANESTHESIA GAS MACHINEFraser Harlake, Inc.1983-11-14600
K831427CYPRANE TEC 4 CONTINUOUS FLOW VAPOR.Fraser Harlake, Inc.1983-07-07650
K822040POWERED EMERGENCY VENTILATORFraser Harlake, Inc.1982-08-19380
K821744FRASER HARLAKE NITRONOX SCAVENGERFraser Harlake, Inc.1982-06-25110
K802943POSITIVE END EXPIRATORY PRESSURE VALVEFraser Harlake, Inc.1981-01-15570

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