510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K901255Substantially Equivalent

Cuff Baro Guard or Cbg Abbreviated

Nelson Engineering, Inc., Guilford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901255 is the FDA 510(k) clearance record for CUFF BARO GUARD OR CBG ABBREVIATED, a class II device, cleared for Nelson Engineering, Inc. on under FDA product code BSK (Cuff, Tracheal Tube, Inflatable). FDA records list one 510(k) clearance for Nelson Engineering, Inc. As of , FDA records show no recalls naming K901255.

Clearance record

Decision date
Received
(13 days to decision)
Product code
BSK Cuff, Tracheal Tube, Inflatable
Regulation
21 CFR 868.5750
Device class
Class II
Review panel
Anesthesiology
Applicant
Nelson Engineering, Inc. 1681 Rt 80, Guilford CT
Third party review
No

Clearances, product code BSK

Trailing 12 months
1 clearance under product code BSK in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BSK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260