510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002795Substantially Equivalent

Model Hybrid 3200 Monoplace, Hyperbaric Therapy Systems

Hypertec, Inc., Deer Field IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002795 is the FDA 510(k) clearance record for MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS, a class II device, cleared for Hypertec, Inc. on under FDA product code CBF (Chamber, Hyperbaric). FDA records list 2 510(k) clearances for Hypertec, Inc. As of , FDA records show no recalls naming K002795.

Clearance record

Decision date
Received
(90 days to decision)
Product code
CBF Chamber, Hyperbaric
Regulation
21 CFR 868.5470
Device class
Class II
Review panel
Anesthesiology
Applicant
Hypertec, Inc. P.O. Box 7007, Deer Field IL
510(k) summary
Summary
Third party review
No

Clearances, product code CBF

Trailing 12 months

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

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