Narco Bio-Systems: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Narco Bio-Systems” (first 1976, latest 1986), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 35 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 | 2 | 2 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 1 |
| DSF | Recorder, Paper Chart | 1 | 1 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 1 | 1 |
| FFX | System, Gastrointestinal Motility (Electrical) | 1 | 1 |
| HCC | Device, Biofeedback | 1 | 1 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Narco Bio-Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853683 | UMS-100 | FAP | 1986-01-10 | 128 |
| K833656 | NARCOTRACE 40 - NT40 | DSF | 1984-05-09 | 202 |
| K832869 | MOTILITY MEASUREMENT SYS MMS-100 | FFX | 1983-10-31 | 68 |
| K813502 | NARCO TELECARE ISOFLO PRESSURE MONITOR | DRS | 1981-12-29 | 14 |
| K811376 | ULTRASONIC QFM SYSTEM 1000 | DPW | 1981-08-13 | 90 |
| K810431 | NARCO TLECARE MINIATURE PRESSURE DOME | DRS | 1981-03-11 | 20 |
| K801544 | PORTA-FIB LPD | LDD | 1980-07-14 | 7 |
| K760084 | MONITOR, GSR (NB-401) | HCC | 1976-07-26 | 35 |
| K760083 | PHYSIOSCOPE | — | 1976-07-20 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Narco Bio-Systems.
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.
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 Scientific (30 510(k)s)
- Narco Air-Shields (19 510(k)s)
- Narco Mckesson Co. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Narco Bio-Systems?
FDA lists 9 510(k) clearances under the applicant name “Narco Bio-Systems” (first 1976, latest 1986), across 8 product codes in 3 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 Bio-Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Narco Bio-Systems is 35 days.
Which FDA product codes appear under Narco Bio-Systems?
The most frequent FDA product codes under this applicant name are DRS (Transducer, Blood-Pressure, Extravascular, 2); DPW (Flowmeter, Blood, Cardiovascular, 1); DSF (Recorder, Paper Chart, 1).
Next steps
- See all 9 Narco Bio-Systems clearances with predicates and recalls
- Run predicate analysis for product code DRS, Narco Bio-Systems'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.