Atlas FDA

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

Teknar, Inc. — Predicate Candidate Screening

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

97 daysmedian FDA review time
272 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K903666OPHTHASONIC A/P IIITeknar, Inc.1990-11-19970
K896038B-SCAN 10 MHZ PROBETeknar, Inc.1990-04-231890
K896150IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONICTeknar, Inc.1990-01-18870
K891777PRO-CUT BIOPSY NEEDLETeknar, Inc.1989-05-04410
K883965PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTORTeknar, Inc.1988-10-05150
K881850TEKNAR PERCU-SCANTeknar, Inc.1988-08-291190
K881605BIOPSY GUIDETeknar, Inc.1988-06-21840
K880659TEKNAR PROSCAN ACCESSORY PROBETeknar, Inc.1988-04-14570
K871536OPHTHASONIC A-SCAN/ B-SCANTeknar, Inc.1987-08-261280
K864807TEKNAR PROSCAN(TM)Teknar, Inc.1987-07-102130
K860757OPHTHASONIC A-SCANTeknar, Inc.1986-12-182930
K850116BETASONIC IIITeknar, Inc.1985-03-29740
K834539AXIPAC IITeknar, Inc.1984-09-112720
K830474IV STANDTeknar, Inc.1983-04-05490
K823011VC IIITeknar, Inc.1982-11-08260
K822900FISCH DRILL PUMPTeknar, Inc.1982-11-08400
K810697AXISONIC IITeknar, Inc.1981-07-131190
K801314VOCON MODEL VC526Teknar, Inc.1980-09-09980

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