KYRClass I
Bag, Ice
21 CFR 880.6050 / General Hospital
KYR is the FDA product code for Bag, Ice, a class I device type, regulated under 21 CFR 880.6050. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- KYR
- Device name
- Bag, Ice
- Regulation
- 21 CFR 880.6050
- Device class
- Class I
- Review panel
- General Hospital
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 4
- Ingested recalls
- 0
Clearances, product code KYR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1978 | 1 |
| 1981 | 1 |
| 1984 | 1 |
Applicants with the most clearances
Product code KYR| Applicant | Clearances |
|---|---|
| Abco Dealers, Inc. | 1 |
| Devon Industries, Inc. | 1 |
| First Industries, Inc. | 1 |
| Sil-Med Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Actlife Technology Co., Ltd - Thanh Hoa Branch
- Aid United International Co., Limited
- All About Inspired Company Limited
- Anhui Ivymed Medical Products Co. Ltd
- Anhui Kamt Ice Pack Co., Ltd.
- Anji Spenq Industrial Co., Ltd.
- Apothecaries Sundries Mfg Pvt Ltd
- Apothecary Products, LLC
- Arlington Specialties, Inc.
- Aspen Surgical Products, Inc.
- Avaline Medical Limited Liability Company
- Beijing Zksk Technology Co., Ltd.
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What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
