FDA product code KYP: Snake Bite Suction Kit
KYP is the FDA product code for snake bite suction kit. It is a Class I device, regulated under 21 CFR 880.5740 and reviewed by the General Hospital panel. FDA has cleared 4 510(k) submissions under KYP, from 4 different applicants. The average 510(k) review took 67 days (median 68).
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Snake Bite Suction Kit |
| Device class | Class I |
| Regulation | 21 CFR 880.5740 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KYP clearance
Top KYP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Marlo Surgical Technology | 1 | 1988-12-09 |
| Medie Group | 1 | 1985-01-23 |
| Saffeta, Inc. | 1 | 1984-07-06 |
| Chiron Vision Corp. | 1 | 1983-05-25 |
Most recent KYP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883839 | Marlo Surgical Technology | ND:YAG LASER SPECTACLES, MST MODEL #YLS-5 | 1988-12-09 | 88 |
| K844048 | Medie Group | DR. HESSEL'S INSECT POISON REMOVER | 1985-01-23 | 98 |
| K842015 | Saffeta, Inc. | SAWYER FIRST AID KIT | 1984-07-06 | 49 |
| K831312 | Chiron Vision Corp. | LOPEZ-HORN CARRIER | 1983-05-25 | 33 |
Recalls for KYP devices
openFDA lists no recalls for product code KYP.
Frequently asked questions
What is FDA product code KYP?
KYP is the FDA product code for snake bite suction kit. It is a Class I device, regulated under 21 CFR 880.5740 and reviewed by the General Hospital panel.
What device class is KYP?
Class I, regulation 21 CFR 880.5740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KYP?
Across 4 cleared submissions the average was 67 days from receipt to decision (median 68).
Which companies have the most KYP clearances?
Marlo Surgical Technology (1); Medie Group (1); Saffeta, Inc. (1); Chiron Vision Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KYP
- Run a recall and safety report across every KYP manufacturer
- Watch product code KYP 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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