510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101262Substantially Equivalent

Flexi-Lite

Pressure-Tech, Inc., Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101262 is the FDA 510(k) clearance record for FLEXI-LITE, a class II device, cleared for Pressure-Tech, Inc. on under FDA product code CBF (Chamber, Hyperbaric). FDA records list one 510(k) clearance for Pressure-Tech, Inc. As of , FDA records show no recalls naming K101262.

Clearance record

Decision date
Received
(36 days to decision)
Product code
CBF Chamber, Hyperbaric
Regulation
21 CFR 868.5470
Device class
Class II
Review panel
Anesthesiology
Applicant
Pressure-Tech, Inc. 55 Northern Blvd., Suite 200, Great Neck NY
510(k) summary
Summary PDF
Third party review
Yes

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