Burdick Corp.: FDA filings under this applicant name
FDA lists 44 510(k) clearances under 2 spellings of the applicant name “Burdick Corp.” (first 1976, latest 1996), across 15 product codes in 4 review panels. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| DPS | Electrocardiograph | 12 | 12 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 5 | 5 |
| LOS | 5 | 5 | |
| DSI | Detector And Alarm, Arrhythmia | 4 | 4 |
| IOL | Treadmill, Powered | 3 | 3 |
| DQA | Oximeter | 2 | 2 |
| DQK | Computer, Diagnostic, Programmable | 2 | 2 |
| DSH | Recorder, Magnetic Tape, Medical | 2 | 2 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 2 | 2 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 2 | 2 |
Plus 5 more product codes.
Review panels
- Cardiovascular (32)
- Physical Medicine (3)
- Anesthesiology (2)
- Neurology (1)
Most recent Burdick Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952417 | QUEST EXERCISE STRESS SYSTEM | DSI | 1996-05-22 | 365 |
| K954267 | BURDICK 200 PULSE OXIMETER | DQA | 1996-05-03 | 234 |
| K946281 | ECLIPSE 4 ELECTROCARDIOGRAPH | LOS | 1996-04-23 | 483 |
| K945985 | PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400 | DQK | 1995-07-03 | 207 |
| K943959 | ECLIPSE 4 ELECTROCARDIOGRAPH | LOS | 1995-05-17 | 275 |
| K942565 | ALTAIR-DISC RECORDER | DQK | 1994-12-05 | 188 |
| K941351 | BURDICK PRO2 OXIMETER | DQA | 1994-10-13 | 205 |
| K942438 | ALTAIR 6100 CASSETTE RECORDER | DSH | 1994-08-05 | 77 |
| K904032 | ELITE II ELECTROCARDIOGRAPH | LOS | 1991-07-24 | 327 |
| K903565 | E560 ELECTROCARDIOGRAPH | LOS | 1991-07-24 | 351 |
34 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Burdick Corp..
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Burdick Corp. (38)
- Burdick, Inc. (6)
Frequently asked questions
How many FDA 510(k) clearances are listed under Burdick Corp.?
FDA lists 44 510(k) clearances under 2 spellings of the applicant name “Burdick Corp.” (first 1976, latest 1996), across 15 product codes in 4 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 Burdick Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Burdick Corp. is 80 days.
Which FDA product codes appear under Burdick Corp.?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 12); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 5); LOS (device, 5).
Next steps
- See all 44 Burdick Corp. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Burdick Corp.'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.