Narco Scientific: FDA filings under this applicant name
FDA lists 30 510(k) clearances under the applicant name “Narco Scientific” (first 1979, latest 1983), plus 1 PMA decision, across 22 product codes in 6 review panels. Median 510(k) review time under this name: 37 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRS | Transducer, Blood-Pressure, Extravascular | 3 | 3 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 | 3 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 2 | 2 |
| FMZ | Incubator, Neonatal | 2 | 2 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 2 | 2 |
| BSZ | Gas-Machine, Anesthesia | 1 | 1 |
| CBK | Ventilator, Continuous, Facility Use | 1 | 1 |
| DPS | Electrocardiograph | 1 | 1 |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
Plus 12 more product codes.
Review panels
- Cardiovascular (12)
- General Hospital (7)
- Anesthesiology (3)
- General and Plastic Surgery (3)
- Ophthalmic (2)
- Ear, Nose and Throat (1)
Most recent Narco Scientific 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K830338 | NARCOTRACE 80 | DXN | 1983-12-22 | 324 |
| K831429 | AS 191 ECG TELEMETRY MODULE | DPS | 1983-10-14 | 164 |
| K831428 | AS 1740 INTERFACE MODULE | DRT | 1983-10-14 | 164 |
| K822835 | PZ-800 VOLUME VENTILATOR | CBK | 1983-09-29 | 373 |
| K831430 | AIR SHIELDS AS-100 MONIORING SYS-AS105 | DRT | 1983-09-12 | 132 |
| K831460 | AS 30/TCP MODULE | KLK | 1983-07-12 | 67 |
| K830123 | DISP. YANKAVER SURG. SUCTION INSTRUMENT | GCY | 1983-06-08 | 148 |
| K831028 | TI-1000 TRANSPORT INCUBATOR | FPL | 1983-05-09 | 40 |
| K823899 | INFANT CARE SYSTEM | FMI | 1983-04-14 | 108 |
| K830680 | AIR-SHIELDS VENTIMETER VENTILATOR-CONTR | BSZ | 1983-04-08 | 35 |
20 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P810007 | PMA | JAUNDICE METER 101 | 1981-11-20 |
Recalls
openFDA lists no recalls under a recalling firm named Narco Scientific.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Narco Scientific (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Narco Air-Shields (19 510(k)s)
- Narco Bio-Systems (9 510(k)s)
- Narco Mckesson Co. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Narco Scientific?
FDA lists 30 510(k) clearances under the applicant name “Narco Scientific” (first 1979, latest 1983), plus 1 PMA decision, across 22 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Narco Scientific?
The median time from FDA receipt to decision across 510(k)s cleared under the name Narco Scientific is 37 days.
Which FDA product codes appear under Narco Scientific?
The most frequent FDA product codes under this applicant name are DRS (Transducer, Blood-Pressure, Extravascular, 3); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 3); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 2).
Next steps
- See all 30 Narco Scientific clearances with predicates and recalls
- Run predicate analysis for product code DRS, Narco Scientific's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.