Quinton, Inc.: FDA clearances and approvals
Quinton, Inc. has 164 FDA 510(k) clearances (first 1976, latest 2003), across 59 product codes in 8 review panels. Median 510(k) review time: 62 days.
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 | 17 | 17 |
| DQY | Catheter, Percutaneous | 9 | 9 |
| IOL | Treadmill, Powered | 9 | 9 |
| FJS | Catheter, Peritoneal, Long-Term Indwelling | 8 | 8 |
| LFJ | Catheter, Subclavian | 8 | 8 |
| DSI | Detector And Alarm, Arrhythmia | 7 | 7 |
| DQK | Computer, Diagnostic, Programmable | 6 | 6 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 6 | 6 |
| DYB | Introducer, Catheter | 5 | 5 |
| FKO | Catheter, Peritoneal Dialysis, Single Use | 5 | 5 |
Plus 49 more product codes.
Review panels
- Cardiovascular (67)
- Gastroenterology and Urology (49)
- General Hospital (16)
- Physical Medicine (14)
- Anesthesiology (6)
- General and Plastic Surgery (6)
- Radiology (2)
- Ear, Nose and Throat (1)
Most recent Quinton, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032038 | PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 | DQK | 2003-09-05 | 66 |
| K021906 | QUINTON Q-CATH, MODEL 000460 | DQK | 2002-09-04 | 86 |
| K003576 | Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 | DSI | 2001-01-25 | 66 |
| K001492 | QUINTON Q-STRESS, MODEL 000483 | DPS | 2000-08-09 | 89 |
| K992908 | Q-TEL TELEMETRY SYSTEM V. 6.0 (ST) | DSI | 2000-03-06 | 189 |
| K990866 | QUINTON MEDTRACK CR PLUS TREADMILL | ISD | 1999-04-29 | 44 |
| K971397 | VIEWCATH 3-D CATHETER PULLBACK | ITX | 1997-08-25 | 132 |
| K964784 | SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) | DPS | 1997-08-13 | 259 |
| K964978 | VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) | DQA | 1997-05-21 | 160 |
| K955002 | MAHURKAR 8 FR DUAL LEMEN CATHETER | MPB | 1996-09-13 | 317 |
154 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Quinton, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Quinton, Inc. have?
Quinton, Inc. has 164 FDA 510(k) clearances (first 1976, latest 2003), across 59 product codes in 8 review panels.
How long does FDA take to clear Quinton, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Quinton, Inc.'s cleared 510(k)s is 62 days.
What devices does Quinton, Inc. make?
Its most frequent FDA product codes are DPS (Electrocardiograph, 17); DQY (Catheter, Percutaneous, 9); IOL (Treadmill, Powered, 9).
Has Quinton, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Quinton, Inc. Related entities may recall under other names.
Next steps
- See all 164 Quinton, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Quinton, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.