First Aid Kit Without Drug
FDA product code OHO · Class I (low risk) · 21 CFR 878.4014 · General, Plastic Surgery
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
0510(k) clearances
0PMA approvals
1recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2837-2026 Class II | Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected…Devices could potentially contain an occluded or partially occluded Guedel Airway tip. | Integrated Medcraft LLC | 07/07/2026Open, Classified |