Atlas FDA

HCB

6 FDA 510(k) clearances · Product code

66 daysmedian time to decision
1321 days90th percentile
6clearances measured

FDA profile

Official device name
Device, Aversive Conditioning
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5235
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
1995: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
GED (GRADUATED ELECTRONIC DECELERATOR (K911820)Behavior Research Institute, Inc.1994-12-05
SIBIS REMOTE ACTUATOR (K871158)Human Technologies, Inc.1987-05-29
SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM (K853178)Oxford Medilog, Inc.1986-02-28
ELECTROSTIMULI AVERSION MACHINE (K820622)Michael R. Kiss1982-04-09
HABITSABATER (K790738)Jackson Ent.1979-06-20
STIMULATOR, SONIC CONTROL (AS-1) (K760166)Farrall Instruments, Inc.1976-07-20

Track HCB automatically

Every clearance here is in the API, with alerts when new ones post.