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

Oratec Interventions, Inc. — Predicate Candidate Screening

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

76 daysmedian FDA review time
203 days90th percentile
24clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K013622NUCLEOTOMY INTRADISCAL CATHETEROratec Interventions, Inc.2002-01-31870
K003198VULCAN TAC PROBES, MODEL 911XXXOratec Interventions, Inc.2001-08-293210
K003893VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEOratec Interventions, Inc.2001-03-01730
K000691VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELSOratec Interventions, Inc.2000-05-04650
K992805ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES)Oratec Interventions, Inc.2000-02-041680
K994333ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIESOratec Interventions, Inc.2000-01-18260
K993967ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002Oratec Interventions, Inc.1999-12-17240
K993854ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIEOratec Interventions, Inc.1999-12-06210
K991140ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SOratec Interventions, Inc.1999-10-252030
K991218ORATEC BIPOLAR ABLATION PROBESOratec Interventions, Inc.1999-09-131540
K992408ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMOratec Interventions, Inc.1999-07-30100
K991190DEFLECTABLE ELECTROSURGICAL PROBESOratec Interventions, Inc.1999-06-23760
K990859DEFLECTABLE TAC ELECTROTHERMAL PROBEOratec Interventions, Inc.1999-06-14900
K990474ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPOratec Interventions, Inc.1999-05-17900
K984185MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILYOratec Interventions, Inc.1998-12-16230
K982971ORATEC TAC-C, MONOPOLAR CAUTERY PROBEOratec Interventions, Inc.1998-11-23900
K974464ORATEC SPINECATH INTRADISCAL CATHETEROratec Interventions, Inc.1998-03-191130
K972358ORATEC MODEL ENDOTAC PROBEOratec Interventions, Inc.1998-01-232120
K973158ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICEOratec Interventions, Inc.1997-11-05750
K973159ORATEC INTERVENTIONS MODEL ORA 40 ELECTROTHERMAL GENERATOROratec Interventions, Inc.1997-09-25340
K965007ORATEC INTERVENTIOUNS ELECTROSURGICAL PROBESOratec Interventions, Inc.1997-02-06520
K964071ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOROratec Interventions, Inc.1996-12-12620
K963157ORATEC INTERVENTIONS MODEL TAC-S MONOPOLAR CAUTERY PROBE (MOOratec Interventions, Inc.1996-09-18550
K954439ORATEC INTERVENTIONS MODEL TAC 1000 MONOPOLAR CAUTERY PROBEOratec Interventions, Inc.1995-12-18840

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