FDA product code DWS: Instruments, Surgical, Cardiovascular
DWS is the FDA product code for instruments, surgical, cardiovascular. It is a Class I device, regulated under 21 CFR 870.4500 and reviewed by the Cardiovascular panel. FDA has cleared 71 510(k) submissions under DWS, from 52 different applicants. The average 510(k) review took 55 days (median 57). FDA has posted 20 recalls for DWS devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Instruments, Surgical, Cardiovascular |
| Device class | Class I |
| Regulation | 21 CFR 870.4500 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DWS clearance
Top DWS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| GE Medical Systems | 3 | 1996-04-19 |
| Pioneering Technologies, Inc. | 3 | 1989-07-14 |
| Manan Manufacturing Co., Inc. | 3 | 1985-07-11 |
| Edward Weck, Inc. | 3 | 1979-12-19 |
| Pilling Co. | 3 | 1976-09-21 |
47 more applicants have DWS clearances. See the full list in Caduvo.
Most recent DWS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022238 | Medtronic Vascular | MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 | 2002-10-09 | 90 |
| K964445 | Dlp, Inc. | OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) | 1997-01-30 | 85 |
| K962771 | Pilling Weck, Inc. | BURKE CONGENITAL THORACOSCOPY INSTRUMENTS | 1996-11-19 | 126 |
| K955689 | Contour Fabricators of Florida, Inc. | RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY | 1996-05-15 | 153 |
| K960139 | GE Medical Systems | G.E. STERILE ANGIOGRAPHIC TRAY | 1996-04-19 | 94 |
Recalls for DWS devices
20 product recalls in 15 recall events; 7 initiated in the last five years and 8 still open. Most recent: 2025-03-27.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 3 |
| 2022 | 1 |
| 2023 | 5 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code DWS?
DWS is the FDA product code for instruments, surgical, cardiovascular. It is a Class I device, regulated under 21 CFR 870.4500 and reviewed by the Cardiovascular panel.
What device class is DWS?
Class I, regulation 21 CFR 870.4500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DWS?
Across 71 cleared submissions the average was 55 days from receipt to decision (median 57).
Which companies have the most DWS clearances?
GE Medical Systems (3); Pioneering Technologies, Inc. (3); Manan Manufacturing Co., Inc. (3); Edward Weck, Inc. (3); Pilling Co. (3).
Have DWS devices been recalled?
Yes: 20 product recalls across 15 recall events; the most recent began 2025-03-27.
Next steps
- Run an FDA pathway report with predicate devices for product code DWS
- Run a recall and safety report across every DWS manufacturer
- Watch product code DWS 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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