Atlas FDA

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

Teknomed, Inc. — Predicate Candidate Screening

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

207 daysmedian FDA review time
429 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K925395TECHNOMED PULSOLITH 4000 LASER SYSTEMTeknomed, Inc.1993-05-212070
K920708MULTILASE 2500 ATeknomed, Inc.1992-11-052610
K913917MULTILASE 2100 C, 2100 DTeknomed, Inc.1992-11-054290
K913290MULTILASE 2100 ATeknomed, Inc.1992-02-212120
K895178TECHNOMED PULSOLITH LASER SYSTEMTeknomed, Inc.1989-10-06570
K890436TECHNOMED PULSOLITH LASER SYSTEMTeknomed, Inc.1989-03-23550
K790132TECNOTOMOTeknomed, Inc.1979-02-21290

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