Protocol Systems, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Protocol Systems, Inc.” (first 1988, latest 2000), across 12 product codes in 2 review panels. Median 510(k) review time under this name: 98 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 4 | 4 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| DQA | Oximeter | 1 | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 | 1 |
| DSF | Recorder, Paper Chart | 1 | 1 |
| DSI | Detector And Alarm, Arrhythmia | 1 | 1 |
| DSK | Computer, Blood-Pressure | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| FLS | Monitor, Apnea, Facility Use | 1 | 1 |
Plus 2 more product codes.
Review panels
- Cardiovascular (12)
- Anesthesiology (3)
Most recent Protocol Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002725 | MICROPAQ, MODELS 402 AND 404 | DRT | 2000-11-21 | 82 |
| K972121 | ACUITY CENTRAL STATION | MLD | 1997-11-07 | 155 |
| K951246 | PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS | FLS | 1996-02-02 | 319 |
| K945071 | PROPAQ 200 MONITOR | DRT | 1995-05-10 | 208 |
| K935846 | MODEL ACUITY CENTRAL STATION | DSI | 1994-12-05 | 362 |
| K934711 | PROPAQ ECG TELEMETRY OPTION | DRG | 1994-09-01 | 335 |
| K921497 | PROPAQ MONITORS, MODIFICATION | CCK | 1993-03-23 | 377 |
| K914838 | PROPAQ 102,104,106,102EL,104EL,&106EL | MHX | 1992-01-10 | 77 |
| K913193 | MODEL 100 CENTRAL STATION | DQK | 1991-10-16 | 90 |
| K910882 | PROPAQ 102EL, 104EL AND 106EL | DRT | 1991-05-08 | 68 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Protocol Systems, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Protocol Systems, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Protocol Systems, Inc.” (first 1988, latest 2000), across 12 product codes in 2 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 Protocol Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Protocol Systems, Inc. is 98 days.
Which FDA product codes appear under Protocol Systems, Inc.?
The most frequent FDA product codes under this applicant name are DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 4); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 1); DQA (Oximeter, 1).
Next steps
- See all 15 Protocol Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRT, Protocol Systems, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.