510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842015Substantially Equivalent

Sawyer First Aid Kit

Saffeta, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842015 is the FDA 510(k) clearance record for SAWYER FIRST AID KIT, a class I device, cleared for Saffeta, Inc. on under FDA product code KYP (Snake Bite Suction Kit). FDA's definition for product code KYP reads: "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...". FDA records list one 510(k) clearance for Saffeta, Inc. As of , FDA records show no recalls naming K842015.

Clearance record

Decision date
Received
(49 days to decision)
Product code
KYP Snake Bite Suction Kit
Regulation
21 CFR 880.5740
Device class
Class I
Review panel
General Hospital
Applicant
Saffeta, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KYP

Trailing 12 months

FDA records hold no clearances under product code KYP in the trailing twelve months.

FDA records show no clearances under product code KYP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KYP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260