Atlas FDA

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

Harris-Lake, Inc. — Predicate Candidate Screening

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

9 daysmedian FDA review time
90 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K761294RESPIRATORY BLOWERHarris-Lake, Inc.1977-01-03130
K761293RESPIRATORY HUMIDIFIERHarris-Lake, Inc.1977-01-03130
K761295RESP. AIR TEMP. CONTROL & HAZARD MON.Harris-Lake, Inc.1976-12-3090
K760333JAR, COLLECTOR FOR SUCTION SYSTEMSHarris-Lake, Inc.1976-10-27900
K760314FLOWMETER, OXYGENHarris-Lake, Inc.1976-08-0490
K760316REGULATORS, LOW SUCTIONHarris-Lake, Inc.1976-08-0490
K760317REGULATORS, HIGH SUCTIONHarris-Lake, Inc.1976-08-0490

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