Atlas FDA

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

Nova Medical Specialties — Predicate Candidate Screening

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

93 daysmedian FDA review time
139 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K872770DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH.Nova Medical Specialties1987-10-15930
K860526NOVA BALLOON THERMODILUTION PRESSURE TRANS CATHNova Medical Specialties1986-05-02800
K853625NOVA ARTERIAL EMBOLECTOMY CATHETERNova Medical Specialties1986-01-151390
K840009NOVA 12 CARDIAC OUTPUT COMPUTERNova Medical Specialties1984-08-222310
K841639NOVA BALLOON THERMODILUTION CATH.Nova Medical Specialties1984-08-1211420
K841640NOVA BALLOON THERMODILUTION INFUSIONNova Medical Specialties1984-08-121140
K834037HEPARIN COATED BALLOON THERMODILUNova Medical Specialties1984-01-10480
K834036HEPARIN COATED BALLOON THERMODILUNova Medical Specialties1984-01-10480
K832287NOVA BALLOON THERMODILUTION INFUSIONNova Medical Specialties1983-10-199821
K822806BALLOON WEDGE PRESSURE, ANGIOGRAPHICNova Medical Specialties1982-11-014520
K812761FLOW-DIRECTED BALLOON THERMODILUTIONNova Medical Specialties1981-11-02320

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