510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961845Substantially Equivalent

Percupump II with Eda

E-Z-EM, Inc, Westbury NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961845 is the FDA 510(k) clearance record for PERCUPUMP II WITH EDA, a class II device, cleared for E-Z-Em, Inc. on under FDA product code DSB (Plethysmograph, Impedance). FDA records list 56 510(k) clearances for E-Z-Em, Inc., from to . As of , FDA records show no recalls naming K961845.

Clearance record

Decision date
Received
(255 days to decision)
Product code
DSB Plethysmograph, Impedance
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
E-Z-Em, Inc. 717 Main St., Westbury NY
510(k) summary
Statement
Third party review
No

Clearances, product code DSB

Trailing 12 months
2 clearances under product code DSB in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSB, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260