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

Lori Medical Laboratories, Inc. — Predicate Candidate Screening

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

89 daysmedian FDA review time
114 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K973376LORI/LORI, LORI-S (LORI STOCK AID)Lori Medical Laboratories, Inc.1997-10-14360
K972058LORIPRO, LORIPRO IILori Medical Laboratories, Inc.1997-08-15740
K964080LORI HEARING AID SIMULATORLori Medical Laboratories, Inc.1997-01-08890
K952711LORI-ALori Medical Laboratories, Inc.1995-07-03190
K940639LORI-CIC HEARING AIDLori Medical Laboratories, Inc.1994-03-25390
K893722LORI-MODEL H, HALF CONCHA IN-THE-EAR INSTRUMENTLori Medical Laboratories, Inc.1989-09-081140
K893721LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENTLori Medical Laboratories, Inc.1989-09-081140
K893723LORI-MODEL L, CANAL IN-THE-EAR INSTRUMENTLori Medical Laboratories, Inc.1989-09-081140

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