Circulatory Technology, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Circulatory Technology, Inc.” (first 1994, latest 2014), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 126 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 | 1 | 58 |
| 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 |
|---|---|---|---|
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 4 | 4 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 | 2 |
| FIB | Protector, Transducer, Dialysis | 1 | 1 |
| KZD | Infusor, Pressure, For I.V. Bags | 1 | 1 |
| MNJ | Valve, Pressure Relief, Cardiopulmonary Bypass | 1 | 1 |
Review panels
Most recent Circulatory Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140321 | INITARY BETTER BLADDER-PEDIATRIC | DTN | 2014-04-17 | 58 |
| K012942 | THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 | DTN | 2001-11-05 | 66 |
| K001822 | THE V-BAG | DTN | 2000-07-07 | 21 |
| K981284 | BETTER-BLADDER (BB) | DTN | 1998-08-12 | 126 |
| K964205 | BETTER-TUBING | DWF | 1998-04-08 | 537 |
| K964337 | BETTER-BLADDER (BB) | FIB | 1997-05-23 | 204 |
| K961594 | BETTER-VENTER | DWF | 1996-09-05 | 134 |
| K941492 | PRESSURE RELIEF VALVE | MNJ | 1994-10-26 | 212 |
| K942933 | PRESSURE INFUSION CUFF | KZD | 1994-08-25 | 64 |
Recalls
7 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2021-04-27.
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 Circulatory Technology, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Circulatory Technology, Inc.” (first 1994, latest 2014), across 5 product codes in 3 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 Circulatory Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Circulatory Technology, Inc. is 126 days.
Which FDA product codes appear under Circulatory Technology, Inc.?
The most frequent FDA product codes under this applicant name are DTN (Reservoir, Blood, Cardiopulmonary Bypass, 4); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 2); FIB (Protector, Transducer, Dialysis, 1).
Next steps
- See all 9 Circulatory Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DTN, Circulatory Technology, 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.