510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853178Substantially Equivalent

Sibis Self Injurious Behavior Inhibiting System

Oxford Medilog, Inc., Clearwater FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853178 is the FDA 510(k) clearance record for SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM, a class II device, cleared for Oxford Medilog, Inc. on under FDA product code HCB (Device, Aversive Conditioning). FDA records list 48 510(k) clearances for Oxford Medilog, Inc., from to . As of , FDA records show no recalls naming K853178.

Clearance record

Decision date
Received
(213 days to decision)
Product code
HCB Device, Aversive Conditioning
Regulation
21 CFR 882.5235
Device class
Class II
Review panel
Neurology
Applicant
Oxford Medilog, Inc. 11526 53rd. St. N., Clearwater FL
Third party review
No

Clearances, product code HCB

Trailing 12 months

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

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