FDA product code KCY: Tourniquet, Pneumatic
KCY is the FDA product code for tourniquet, pneumatic. It is a Class I device, regulated under 21 CFR 878.5910 and reviewed by the General and Plastic Surgery panel. FDA has cleared 34 510(k) submissions under KCY, from 25 different applicants. The average 510(k) review took 104 days (median 66). FDA has posted 47 recalls for KCY devices, 15 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tourniquet, Pneumatic |
| Device class | Class I |
| Regulation | 21 CFR 878.5910 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
510(k) clearances per year for KCY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 177 |
| 2021 | 1 | 233 |
Compare with all 510(k) review times · Search every KCY clearance
Top KCY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Instrumed, Inc. | 5 | 1995-07-11 |
| Aspen Laboratories, Inc. | 5 | 1987-03-18 |
| Zimmer, Inc. | 2 | 2013-08-09 |
| Mcewen and Associates Consulting , Ltd. | 1 | 2021-05-20 |
| Terumobct, Inc. | 1 | 2017-02-16 |
20 more applicants have KCY clearances. See the full list in Caduvo.
Most recent KCY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K202919 | Mcewen and Associates Consulting , Ltd. | ATS 5000 Automatic Tourniquet Instrument | 2021-05-20 | 233 |
| K162365 | Terumobct, Inc. | T-Cuff | 2017-02-16 | 177 |
| K123553 | Zimmer, Inc. | ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM | 2013-08-09 | 263 |
| K112874 | Dominion Medical Devices, LLC | EZ VEIN INFLATABLE TOURNIQUET | 2011-10-17 | 17 |
| K071140 | Top Spins, Inc. | MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 | 2007-06-07 | 44 |
Recalls for KCY devices
47 product recalls in 27 recall events; 15 initiated in the last five years and 14 still open. Most recent: 2026-06-09.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2019 | 5 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 7 |
| 2024 | 1 |
| 2025 | 3 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code KCY?
KCY is the FDA product code for tourniquet, pneumatic. It is a Class I device, regulated under 21 CFR 878.5910 and reviewed by the General and Plastic Surgery panel.
What device class is KCY?
Class I, regulation 21 CFR 878.5910. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KCY?
Across 34 cleared submissions the average was 104 days from receipt to decision (median 66).
Which companies have the most KCY clearances?
Instrumed, Inc. (5); Aspen Laboratories, Inc. (5); Zimmer, Inc. (2); Mcewen and Associates Consulting , Ltd. (1); Terumobct, Inc. (1).
Have KCY devices been recalled?
Yes: 47 product recalls across 27 recall events; the most recent began 2026-06-09.
Next steps
- Run an FDA pathway report with predicate devices for product code KCY
- Run a recall and safety report across every KCY manufacturer
- Watch product code KCY 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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