Sub-Q, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Sub-Q, Inc.” (first 1998, latest 1999), plus 1 PMA decision, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 124 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 |
|---|---|---|---|
| KYZ | Syringe, Irrigating (Non Dental) | 2 | 2 |
| MGB | Device, Hemostasis, Vascular | 1 | 0 |
Review panels
- General Hospital (2)
- Cardiovascular (1)
Most recent Sub-Q, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991254 | QS DELIVERY SYSTEM | KYZ | 1999-08-23 | 132 |
| K982435 | IRRIGATION SYRINGE KIT | KYZ | 1998-11-06 | 116 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P010049 | PMA | QUICKSEAL FEMORAL ARTERIAL CLOSURE SYSTEM | 2002-03-25 |
Recalls
openFDA lists no recalls under a recalling firm named Sub-Q, 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 Sub-Q, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Sub-Q, Inc.” (first 1998, latest 1999), plus 1 PMA decision, across 2 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 Sub-Q, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sub-Q, Inc. is 124 days.
Which FDA product codes appear under Sub-Q, Inc.?
The most frequent FDA product codes under this applicant name are KYZ (Syringe, Irrigating (Non Dental), 2); MGB (Device, Hemostasis, Vascular, 1).
Next steps
- See all 2 Sub-Q, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KYZ, Sub-Q, 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.