510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011046Substantially Equivalent

Autopulse, Model 100

Revivant Corp., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011046 is the FDA 510(k) clearance record for AUTOPULSE, MODEL 100, a class II device, cleared for Revivant Corp. on under FDA product code DRM (Compressor, Cardiac, External). FDA records list 4 510(k) clearances for Revivant Corp., from to . As of , FDA records show 2 recalls naming K011046.

Clearance record

Decision date
Received
(202 days to decision)
Product code
DRM Compressor, Cardiac, External
Regulation
21 CFR 870.5200
Device class
Class II
Review panel
Cardiovascular
Applicant
Revivant Corp. 775 Palomar, Sunnyvale CA
510(k) summary
Summary
Third party review
No

Clearances, product code DRM

Trailing 12 months

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

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