Quest Medical, Inc.: FDA filings under this applicant name
FDA lists 39 510(k) clearances under the applicant name “Quest Medical, Inc.” (first 1980, latest 2024), across 14 product codes in 6 review panels. Median 510(k) review time under this name: 111 days. Since 2017 the median was 154 days, against 168 days for all cleared 510(k)s in the same product codes. 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 | 2 | 289 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 161 |
| 2016 | 1 | 111 |
| 2017 | 1 | 154 |
| 2018 | 2 | 180 |
| 2019 | 0 | — |
| 2020 | 2 | 121 |
| 2021 | 1 | 128 |
| 2022 | 2 | 190 |
| 2023 | 0 | — |
| 2024 | 1 | 244 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Quest Medical, Inc. took a median 154 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 168 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 12 | 12 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 8 | 8 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 5 | 5 |
| FRN | Pump, Infusion | 2 | 2 |
| LDR | Controller, Infusion, Intravascular, Electronic | 2 | 2 |
| OKS | Lacrimal Stents And Intubation Sets | 2 | 2 |
| BTC | Bag, Reservoir | 1 | 1 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
Plus 4 more product codes.
Review panels
- General Hospital (18)
- Cardiovascular (16)
- Ophthalmic (2)
- Anesthesiology (1)
- Clinical Chemistry (1)
- General and Plastic Surgery (1)
Most recent Quest Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241058 | Lyka® PORT Needle Free Access Device (4170Y) | FPA | 2024-12-18 | 244 |
| K213846 | Q2 Blood Administration Sets | FPA | 2022-06-05 | 177 |
| K213588 | Q2 IV Administration Sets | FPA | 2022-06-02 | 202 |
| K202672 | Precision Delivery Infusion Set | FPA | 2021-01-21 | 128 |
| K201984 | MPS 3 ND Myocardial Protection System | DTR | 2020-11-20 | 126 |
| K200438 | MPS 3 Myocardial Protection System | DTR | 2020-06-19 | 116 |
| K182442 | MiniGuard Arterial Safety Valve | MJJ | 2018-11-06 | 60 |
| K173716 | MPS2 Myocardial Protection System Console | DTR | 2018-10-01 | 300 |
| K162804 | Q2 Low Pressure Power Injection Extension Set | FPA | 2017-03-08 | 154 |
| K162304 | Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets | FPA | 2016-12-06 | 111 |
29 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 7 recall events; 2 initiated in the last five years. Most recent: 2023-07-14.
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 Quest Medical, Inc. (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 JCY)
- 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.
- Quest Intl., Inc. (25 510(k)s)
- Quest Diagnostics, Inc. (8 510(k)s)
- Quest International, Inc. (3 510(k)s)
- Quest Dental USA Corp. (2 510(k)s)
- Quest Medical Imaging (2 510(k)s)
- Quest Enabling Designs , Ltd. (1 510(k)s)
- Quest Diagnostics Nichols Institute (0 510(k)s)
- Quest Technologies Corp. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Quest Medical, Inc.?
FDA lists 39 510(k) clearances under the applicant name “Quest Medical, Inc.” (first 1980, latest 2024), across 14 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 Quest Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Quest Medical, Inc. is 111 days. Since 2017: 154 days, versus 168 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Quest Medical, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 12); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 8); DTR (Heat-Exchanger, Cardiopulmonary Bypass, 5).
Next steps
- See all 39 Quest Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Quest Medical, 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 (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.