Atlas FDA

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

Telos Medical Corp. · Predicate Candidate Screening

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

90 daysmedian FDA review time
504 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K920375DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCERTelos Medical Corp.1992-10-272720
K920044DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KITTelos Medical Corp.1992-04-03880
K914387TRANSCERVICAL INTRAUTERINE KITTelos Medical Corp.1991-12-30900
K905018LAB-SITE SAFETY NEEDLETelos Medical Corp.1991-01-16700
K905017LAB-SITETelos Medical Corp.1991-01-15690
K882224ULTRANS DISPOSABLE INTRAUTERINETelos Medical Corp.1989-10-125040
K883832CATHETER, INTRAUTERINE AND INTRODUCERTelos Medical Corp.1988-12-13950

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