510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881725Substantially Equivalent

Envirotent (Bed)

Envirotents, Inc., Denver CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881725 is the FDA 510(k) clearance record for ENVIROTENT (BED), a class I device, cleared for Envirotents, Inc. on under FDA product code FNJ (Bed, Manual). FDA records list one 510(k) clearance for Envirotents, Inc. As of , FDA records show no recalls naming K881725.

Clearance record

Decision date
Received
(200 days to decision)
Product code
FNJ Bed, Manual
Regulation
21 CFR 880.5120
Device class
Class I
Review panel
General Hospital
Applicant
Envirotents, Inc. 1550 S. Pearl St., #210-D, Denver CO
Third party review
No

Clearances, product code FNJ

Trailing 12 months

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

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