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

Vlv Associates, Inc. — Predicate Candidate Screening

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

93 daysmedian FDA review time
242 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K972957SA-EF MULTI-LUMEN EXTENSION SETVlv Associates, Inc.1997-09-29490
K964876SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SETVlv Associates, Inc.1997-02-28850
K955783VLV SA.EF INFUSION PORT EXTENSION SETSVlv Associates, Inc.1996-02-07480
K953791VLV SA EF INFUSION PORTVlv Associates, Inc.1995-10-30770
K945592VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGEVlv Associates, Inc.1995-07-142420
K940406DISPOSABLE, AMBULATORY, INFUSION PUMPSVlv Associates, Inc.1994-09-022180
K933364PROMED BIOPSY NEEDLEVlv Associates, Inc.1994-02-152210
K922469PRO-LOK EXTENSION SET(S)Vlv Associates, Inc.1993-03-152930
K904217PRO-LOK (TM) EXTENSION SETSVlv Associates, Inc.1990-10-03210
K901081PRO-LOCK(TM) SHIELDING NEEDLE CONNECTOR ASSEMBLYVlv Associates, Inc.1990-06-08930
K901046VERSA-LOCK(TM) UNIVERSAL NEEDLE CONNECTORVlv Associates, Inc.1990-06-08940
K860071HOLD-IT FRAMED ADHESIVE FILMVlv Associates, Inc.1986-01-27210

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