Catheter Research, Inc.: FDA clearances and approvals
Catheter Research, Inc. has 8 FDA 510(k) clearances (first 1994, latest 2013), across 5 product codes in 2 review panels. Median 510(k) review time: 77 days. openFDA lists 2 product recalls by a recalling firm named Catheter Research, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 63 |
| 2013 | 1 | 105 |
| 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 |
|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | 4 | 4 |
| BZA | Connector, Airway (Extension) | 1 | 1 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 1 | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| MQF | Catheter, Assisted Reproduction | 1 | 1 |
Review panels
Most recent Catheter Research, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123258 | THE ADVANCE CATHETER FOR HSG AND SIS | LKF | 2013-01-31 | 105 |
| K120154 | INTRAUTERINE INSEMINATION (IUI) CATHETER | MQF | 2012-03-21 | 63 |
| K032835 | H/S CATHETER SET | LKF | 2003-12-11 | 91 |
| K020292 | UTERINE INJECTOR | LKF | 2002-04-17 | 79 |
| K973839 | DISPOSABLE ESOPHAGEAL STETHOSCOPE | BZT | 1998-03-19 | 162 |
| K974357 | UTERINE MANIPULATOR/INJECTOR | LKF | 1998-02-02 | 75 |
| K951345 | DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING | BZA | 1995-04-14 | 22 |
| K946044 | DISPOSABLE GAS SAMPLING LINES | CCK | 1994-12-27 | 15 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2015-04-07.
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 Catheter Research, Inc. have?
Catheter Research, Inc. has 8 FDA 510(k) clearances (first 1994, latest 2013), across 5 product codes in 2 review panels.
How long does FDA take to clear Catheter Research, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Catheter Research, Inc.'s cleared 510(k)s is 77 days.
What devices does Catheter Research, Inc. make?
Its most frequent FDA product codes are LKF (Cannula, Manipulator/Injector, Uterine, 4); BZA (Connector, Airway (Extension), 1); BZT (Stethoscope, Esophageal, With Electrical Conductors, 1).
Has Catheter Research, Inc. had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Catheter Research, Inc; the most recent began 2015-04-07. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 8 Catheter Research, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LKF, Catheter Research, 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.