FDA product code KYR: Bag, Ice
KYR is the FDA product code for bag, ice. It is a Class I device, regulated under 21 CFR 880.6050 and reviewed by the General Hospital panel. FDA has cleared 4 510(k) submissions under KYR, from 4 different applicants. The average 510(k) review took 55 days (median 58).
Classification
| Field | Value |
|---|---|
| Device name | Bag, Ice |
| Device class | Class I |
| Regulation | 21 CFR 880.6050 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KYR clearance
Top KYR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sil-Med Corp. | 1 | 1984-02-04 |
| First Industries, Inc. | 1 | 1981-03-27 |
| Abco Dealers, Inc. | 1 | 1978-06-06 |
| Devon Industries, Inc. | 1 | 1976-12-30 |
Most recent KYR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K833872 | Sil-Med Corp. | SAV-A-LIMB | 1984-02-04 | 88 |
| K810653 | First Industries, Inc. | VINYL ICE BAG | 1981-03-27 | 17 |
| K780608 | Abco Dealers, Inc. | ICE BAG, VINYL | 1978-06-06 | 57 |
| K760951 | Devon Industries, Inc. | DEVON COOL FACE | 1976-12-30 | 59 |
Recalls for KYR devices
openFDA lists no recalls for product code KYR.
Frequently asked questions
What is FDA product code KYR?
KYR is the FDA product code for bag, ice. It is a Class I device, regulated under 21 CFR 880.6050 and reviewed by the General Hospital panel.
What device class is KYR?
Class I, regulation 21 CFR 880.6050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KYR?
Across 4 cleared submissions the average was 55 days from receipt to decision (median 58).
Which companies have the most KYR clearances?
Sil-Med Corp. (1); First Industries, Inc. (1); Abco Dealers, Inc. (1); Devon Industries, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KYR
- Run a recall and safety report across every KYR manufacturer
- Watch product code KYR 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.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times