Atlas FDA

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

Medtronic PS Medical · Predicate Candidate Screening

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

90 daysmedian FDA review time
224 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K012052MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 9286Medtronic PS Medical2002-02-112240
K010361MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 6Medtronic PS Medical2001-05-07900
K010487BIPOLAR PENCIL, MODEL 3901-002, 3900-002Medtronic PS Medical2001-05-03720
K010341MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2Medtronic PS Medical2001-04-20742
K003914MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORMedtronic PS Medical2001-02-22650
K002572MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001Medtronic PS Medical2000-11-16900
K991502MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116Medtronic PS Medical2000-09-125020
K990333MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3Medtronic PS Medical1999-04-28842
K984053BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEMMedtronic PS Medical1999-02-04906
K983799MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEMedtronic PS Medical1999-01-26900
K983331MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM Medtronic PS Medical1998-12-168529
K981046MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) Medtronic PS Medical1998-06-16880
K970341MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KITMedtronic PS Medical1997-04-23840
K961336MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652Medtronic PS Medical1996-07-181010

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