Atlas FDA

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

Narco Scientific — Predicate Candidate Screening

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

38 daysmedian FDA review time
164 days90th percentile
30clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K830338NARCOTRACE 80Narco Scientific1983-12-223240
K831429AS 191 ECG TELEMETRY MODULENarco Scientific1983-10-141640
K831428AS 1740 INTERFACE MODULENarco Scientific1983-10-141640
K822835PZ-800 VOLUME VENTILATORNarco Scientific1983-09-293730
K831430AIR SHIELDS AS-100 MONIORING SYS-AS105Narco Scientific1983-09-121320
K831460AS 30/TCP MODULENarco Scientific1983-07-12670
K830123DISP. YANKAVER SURG. SUCTION INSTRUMENTNarco Scientific1983-06-081480
K831028TI-1000 TRANSPORT INCUBATORNarco Scientific1983-05-09400
K823899INFANT CARE SYSTEMNarco Scientific1983-04-141080
K830680AIR-SHIELDS VENTIMETER VENTILATOR-CONTRNarco Scientific1983-04-08350
K830654INFUSION PUMP RETROGRADE EXTEN. AS 715Narco Scientific1983-03-24230
K822961PORTA FIB IIINarco Scientific1982-11-01270
K822656C-200 INFANT INCUBATORNarco Scientific1982-10-18450
K822747PILLING LACRIMAL INTUBATION SYSTEM(STER.Narco Scientific1982-10-18380
K822748PILLING COIN-STYLE BLADE GAUGENarco Scientific1982-10-06260
K822749PILLING DIAMOND KNIFENarco Scientific1982-10-06260
K821896C-300 INFANT INCUBATORNarco Scientific1982-07-28300
K821614AS20 MONITORING SYSTEMNarco Scientific1982-07-14420
K821378NON-INVASIVE AUTOMATIC BLOOD PRESSURENarco Scientific1982-07-08590
K821377AS 700 SERIES INFUSION PUMP ADMIN.Narco Scientific1982-07-02530
K820946AS 70 VOLUMETRIC INFUSION PUMPNarco Scientific1982-04-29230
K820377PILLING IDENTI-LOOPSNarco Scientific1982-03-10290
K813187PILLING LACRIMAL INTUBATION SYSTEMNarco Scientific1982-01-28730
K813471LINE POWERED LOW ENERGY DEFIBRILLATOR IINarco Scientific1981-12-29150
K812918PILLING K KNIFENarco Scientific1981-11-06180
K812883TELECARE ISOTEC PRESSURE TRANSDUCER DOMENarco Scientific1981-11-02190
K812884NARCO TELECARE PRESSURE TRANSDUCER DOMENarco Scientific1981-11-02190
K811496GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM.Narco Scientific1981-06-16200
K803096NARCO TELECARE TRANSDUCER DOME #700-4000Narco Scientific1981-01-13360
K790124GRAFT TUNNELERNarco Scientific1979-02-08160

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