510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K872038Substantially Equivalent

Neb-U-Vent

Design Technologies, Inc., Rahway NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872038 is the FDA 510(k) clearance record for NEB-U-VENT, a class I device, cleared for Design Technologies, Inc. on under FDA product code CCN (Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge). FDA records list 4 510(k) clearances for Design Technologies, Inc., from to . As of , FDA records show no recalls naming K872038.

Clearance record

Decision date
Received
(75 days to decision)
Product code
CCN Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
Regulation
21 CFR 868.2300
Device class
Class I
Review panel
Anesthesiology
Applicant
Design Technologies, Inc. 1471 Pinewood St., Rahway NJ
Third party review
No

Clearances, product code CCN

Trailing 12 months

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

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