510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101831Substantially Equivalent

Enterix Insurefit Fob Controls, Model 16800

Bionostics, Inc., Devens MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101831 is the FDA 510(k) clearance record for ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800, a class II device, cleared for Bionostics, Inc. on under FDA product code OSL (Control, Fecal Occult Blood). FDA's definition for product code OSL reads: "Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices". FDA records list 49 510(k) clearances for Bionostics, Inc., from to . As of , FDA records show no recalls naming K101831.

Clearance record

Decision date
Received
(92 days to decision)
Product code
OSL Control, Fecal Occult Blood
Regulation
21 CFR 864.6550
Device class
Class II
Review panel
Hematology
Applicant
Bionostics, Inc. 7 Jackson Rd., Devens MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OSL

Trailing 12 months

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

FDA records show no clearances under product code OSL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OSL, 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