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

Pioneering Technologies, Inc. — Predicate Candidate Screening

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

84 daysmedian FDA review time
417 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K922025ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIFPioneering Technologies, Inc.1992-09-221680
K905175PTI ANNULOPLASTY RING(STERILE)Pioneering Technologies, Inc.1992-02-144520
K905068PTI INTRA-ART (TM) PICK-UP WICKSPioneering Technologies, Inc.1991-12-314170
K910067PTI STERNAL CLOSURE WIRE SUTUREPioneering Technologies, Inc.1991-05-061170
K905067PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFTPioneering Technologies, Inc.1991-03-181290
K901815MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARYPioneering Technologies, Inc.1990-07-03710
K901682PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERSPioneering Technologies, Inc.1990-07-03840
K901531PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBEPioneering Technologies, Inc.1990-06-20900
K901575REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTRODPioneering Technologies, Inc.1990-05-02291
K897075PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDERPioneering Technologies, Inc.1990-04-101110
K894684PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KITPioneering Technologies, Inc.1989-10-17840
K891786PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)Pioneering Technologies, Inc.1989-10-122020
K893436MODIFIED STERILIZATION METHOD OF PTI HEART-LIFTPioneering Technologies, Inc.1989-07-14720
K883221PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KITPioneering Technologies, Inc.1988-10-13760
K882981PTI INTRA-ART CORONARY ARTERY RETRACTION CLIPPioneering Technologies, Inc.1988-09-27740
K883135PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE)Pioneering Technologies, Inc.1988-09-26620
K882879PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER)Pioneering Technologies, Inc.1988-09-12630
K882381PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERIPioneering Technologies, Inc.1988-07-07280
K874927PTI HEART-CHILL(TM) CARDIAC INSULATING JACKETPioneering Technologies, Inc.1988-01-29580

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