FDA product code MWS: Stabilizer, Heart
MWS is the FDA product code for stabilizer, heart. It is a Class I device, regulated under 21 CFR 870.4500 and reviewed by the Cardiovascular panel. FDA has cleared 4 510(k) submissions under MWS, from 4 different applicants. The average 510(k) review took 184 days (median 132). FDA has posted 17 recalls for MWS devices, 9 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Stabilizer, Heart |
| 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 MWS clearance
Top MWS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Vascular | 1 | 2004-07-19 |
| Pilling Weck Surgical | 1 | 2000-09-13 |
| Cardio Thoracic Systems | 1 | 1999-11-10 |
| Cardiothoracic Systems, Inc. | 1 | 1999-01-13 |
Most recent MWS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K041338 | Medtronic Vascular | MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES | 2004-07-19 | 60 |
| K992476 | Pilling Weck Surgical | PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS | 2000-09-13 | 415 |
| K992833 | Cardio Thoracic Systems | VACUUM ASSIST STABILIZER | 1999-11-10 | 79 |
| K982419 | Cardiothoracic Systems, Inc. | HEART-LIFT BALLOON POSITIONER | 1999-01-13 | 184 |
Recalls for MWS devices
17 product recalls in 11 recall events; 9 initiated in the last five years and 9 still open. Most recent: 2026-05-12.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2023 | 2 |
| 2024 | 3 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code MWS?
MWS is the FDA product code for stabilizer, heart. It is a Class I device, regulated under 21 CFR 870.4500 and reviewed by the Cardiovascular panel.
What device class is MWS?
Class I, regulation 21 CFR 870.4500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MWS?
Across 4 cleared submissions the average was 184 days from receipt to decision (median 132).
Which companies have the most MWS clearances?
Medtronic Vascular (1); Pilling Weck Surgical (1); Cardio Thoracic Systems (1); Cardiothoracic Systems, Inc. (1).
Have MWS devices been recalled?
Yes: 17 product recalls across 11 recall events; the most recent began 2026-05-12.
Next steps
- Run an FDA pathway report with predicate devices for product code MWS
- Run a recall and safety report across every MWS manufacturer
- Watch product code MWS 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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