Atlas FDA

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

Lares Manufacturing Co., Inc. · Predicate Candidate Screening

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

11 daysmedian FDA review time
203 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K831351PERMALUX VISIBLE CURE COMPOSITE RESTORLares Manufacturing Co., Inc.1983-11-142030
K801535LARES HANDPIECE OILLares Manufacturing Co., Inc.1980-12-161660
K801592FIBER OPTIC HOSELares Manufacturing Co., Inc.1980-07-21100
K801591FIBER OPTIC ILLUMINATORLares Manufacturing Co., Inc.1980-07-21100
K801534LARES AIR PRESSURE GAUGELares Manufacturing Co., Inc.1980-07-14110
K780038DENTAL HANDPIECELares Manufacturing Co., Inc.1978-01-20110

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