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-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K830338 | NARCOTRACE 80 | Narco Scientific | 1983-12-22 | 324 | 0 |
| K831429 | AS 191 ECG TELEMETRY MODULE | Narco Scientific | 1983-10-14 | 164 | 0 |
| K831428 | AS 1740 INTERFACE MODULE | Narco Scientific | 1983-10-14 | 164 | 0 |
| K822835 | PZ-800 VOLUME VENTILATOR | Narco Scientific | 1983-09-29 | 373 | 0 |
| K831430 | AIR SHIELDS AS-100 MONIORING SYS-AS105 | Narco Scientific | 1983-09-12 | 132 | 0 |
| K831460 | AS 30/TCP MODULE | Narco Scientific | 1983-07-12 | 67 | 0 |
| K830123 | DISP. YANKAVER SURG. SUCTION INSTRUMENT | Narco Scientific | 1983-06-08 | 148 | 0 |
| K831028 | TI-1000 TRANSPORT INCUBATOR | Narco Scientific | 1983-05-09 | 40 | 0 |
| K823899 | INFANT CARE SYSTEM | Narco Scientific | 1983-04-14 | 108 | 0 |
| K830680 | AIR-SHIELDS VENTIMETER VENTILATOR-CONTR | Narco Scientific | 1983-04-08 | 35 | 0 |
| K830654 | INFUSION PUMP RETROGRADE EXTEN. AS 715 | Narco Scientific | 1983-03-24 | 23 | 0 |
| K822961 | PORTA FIB III | Narco Scientific | 1982-11-01 | 27 | 0 |
| K822656 | C-200 INFANT INCUBATOR | Narco Scientific | 1982-10-18 | 45 | 0 |
| K822747 | PILLING LACRIMAL INTUBATION SYSTEM(STER. | Narco Scientific | 1982-10-18 | 38 | 0 |
| K822748 | PILLING COIN-STYLE BLADE GAUGE | Narco Scientific | 1982-10-06 | 26 | 0 |
| K822749 | PILLING DIAMOND KNIFE | Narco Scientific | 1982-10-06 | 26 | 0 |
| K821896 | C-300 INFANT INCUBATOR | Narco Scientific | 1982-07-28 | 30 | 0 |
| K821614 | AS20 MONITORING SYSTEM | Narco Scientific | 1982-07-14 | 42 | 0 |
| K821378 | NON-INVASIVE AUTOMATIC BLOOD PRESSURE | Narco Scientific | 1982-07-08 | 59 | 0 |
| K821377 | AS 700 SERIES INFUSION PUMP ADMIN. | Narco Scientific | 1982-07-02 | 53 | 0 |
| K820946 | AS 70 VOLUMETRIC INFUSION PUMP | Narco Scientific | 1982-04-29 | 23 | 0 |
| K820377 | PILLING IDENTI-LOOPS | Narco Scientific | 1982-03-10 | 29 | 0 |
| K813187 | PILLING LACRIMAL INTUBATION SYSTEM | Narco Scientific | 1982-01-28 | 73 | 0 |
| K813471 | LINE POWERED LOW ENERGY DEFIBRILLATOR II | Narco Scientific | 1981-12-29 | 15 | 0 |
| K812918 | PILLING K KNIFE | Narco Scientific | 1981-11-06 | 18 | 0 |
| K812883 | TELECARE ISOTEC PRESSURE TRANSDUCER DOME | Narco Scientific | 1981-11-02 | 19 | 0 |
| K812884 | NARCO TELECARE PRESSURE TRANSDUCER DOME | Narco Scientific | 1981-11-02 | 19 | 0 |
| K811496 | GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM. | Narco Scientific | 1981-06-16 | 20 | 0 |
| K803096 | NARCO TELECARE TRANSDUCER DOME #700-4000 | Narco Scientific | 1981-01-13 | 36 | 0 |
| K790124 | GRAFT TUNNELER | Narco Scientific | 1979-02-08 | 16 | 0 |
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