FDA product code OWQ: Reprocessed Intravascular Ultrasound Catheter
OWQ is the FDA product code for reprocessed intravascular ultrasound catheter. It is a Class II device, regulated under 21 CFR 870.1200 and reviewed by the Cardiovascular panel. FDA has cleared 31 510(k) submissions under OWQ, 15 in the last five years, from 11 different applicants. The average 510(k) review took 174 days (median 147); 188 days on average over the last three years. FDA has posted 10 recalls for OWQ devices, 7 initiated in the last five years.
Definition
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Classification
| Field | Value |
|---|---|
| Device name | Reprocessed Intravascular Ultrasound Catheter |
| Device class | Class II |
| Regulation | 21 CFR 870.1200 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for OWQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 162 |
| 2018 | 1 | 146 |
| 2019 | 3 | 261 |
| 2020 | 1 | 120 |
| 2022 | 2 | 297 |
| 2023 | 8 | 86 |
| 2024 | 1 | 263 |
| 2025 | 3 | 112 |
| 2026 | 1 | 189 |
Compare with all 510(k) review times · Search every OWQ clearance
Top OWQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Innovative Health, LLC | 7 | 2022-05-25 |
| Sterilmed, Inc. | 6 | 2026-06-29 |
| Surgical Instrument Service and Savings, Inc. | 3 | 2025-06-05 |
| Vein 360, LLC | 3 | 2023-10-24 |
| ABBOTT MEDICAL | 3 | 2023-06-30 |
6 more applicants have OWQ clearances. See the full list in Caduvo.
Most recent OWQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254149 | Sterilmed, Inc. | Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485) | 2026-06-29 | 189 |
| K250545 | Surgical Instrument Service and Savings, Inc. | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) | 2025-06-05 | 100 |
| K250592 | Northeast Scientific, Inc. | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) | 2025-05-12 | 74 |
| K243101 | Surgical Instrument Service and Savings, Inc. | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) | 2025-03-10 | 161 |
| K234064 | Surgical Instrument Service and Savings, Inc. | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910) | 2024-09-10 | 263 |
Recalls for OWQ devices
10 product recalls in 6 recall events; 7 initiated in the last five years and 7 still open. Most recent: 2025-12-22.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 1 |
| 2025 | 7 |
Frequently asked questions
What is FDA product code OWQ?
OWQ is the FDA product code for reprocessed intravascular ultrasound catheter. It is a Class II device, regulated under 21 CFR 870.1200 and reviewed by the Cardiovascular panel.
What device class is OWQ?
Class II, regulation 21 CFR 870.1200. Typical premarket route: 510(k).
How long does a 510(k) take for product code OWQ?
Across 31 cleared submissions the average was 174 days from receipt to decision (median 147).
Which companies have the most OWQ clearances?
Innovative Health, LLC (7); Sterilmed, Inc. (6); Surgical Instrument Service and Savings, Inc. (3); Vein 360, LLC (3); ABBOTT MEDICAL (3).
Have OWQ devices been recalled?
Yes: 10 product recalls across 6 recall events; the most recent began 2025-12-22.
Next steps
- Run an FDA pathway report with predicate devices for product code OWQ
- Run a recall and safety report across every OWQ manufacturer
- Watch product code OWQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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