Atlas FDA

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

Karlin Technology, Inc. — Predicate Candidate Screening

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

31 daysmedian FDA review time
343 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K903969SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RETKarlin Technology, Inc.1990-09-0580
K893203BONE SCREWKarlin Technology, Inc.1990-04-043430
K893201BONE PLATEKarlin Technology, Inc.1990-04-043430
K882525SPINAL MICROKNIFEKarlin Technology, Inc.1988-09-22970
K882519X-RAY MARKERKarlin Technology, Inc.1988-08-09530
K882520SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADSKarlin Technology, Inc.1988-07-18310
K882073SPINAL NEEDLEKarlin Technology, Inc.1988-07-18620
K882524UNIVERSALLY ADJUSTABLE ARMBOARDKarlin Technology, Inc.1988-07-08210
K882077MICRODISCECTOMY CURRETTESKarlin Technology, Inc.1988-06-17310
K882069SPINAL DISTRACTORS, SPANNERSKarlin Technology, Inc.1988-06-17310
K882072ORTHOPAEDIC AND SPINAL RING CURRETTESKarlin Technology, Inc.1988-06-17310
K882074SUCTION RETRACTORSKarlin Technology, Inc.1988-06-16300
K882078SPINAL SURGERY FRAMEKarlin Technology, Inc.1988-06-16300
K882075SELF-RETAINING SOFT TISSUE RETRACTORKarlin Technology, Inc.1988-06-16300
K882071CRANK FRAME RETRACTORKarlin Technology, Inc.1988-06-10240
K882068COBB SPINAL ELEVATORSKarlin Technology, Inc.1988-06-03170
K882070LUMBAR IMPACTION SET AND BONE GRAFT IMPACTORSKarlin Technology, Inc.1988-06-03170

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