Cleared Traditional

K961845 - PERCUPUMP II WITH EDA (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961845 · E-Z-Em, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
255d
Days
Class 2
Risk

K961845 is an FDA 510(k) clearance for the PERCUPUMP II WITH EDA. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on January 23, 1997 after a review of 255 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.2770 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all E-Z-Em, Inc. devices

Submission Details

510(k) Number K961845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1996
Decision Date January 23, 1997
Days to Decision 255 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 107d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - DSB Plethysmograph, Impedance

All 113
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K961845.
BCM2-Body Composition Monitor
K250634 · Fresenius Medical Care Renal Therapies Group, LLC · Nov 2025
Re:Balans
K243727 · Mode Sensors AS · Oct 2025
Edema Guard Monitor (EGM) CardioSet-001
K250922 · Cardioset Medical , Ltd. · Sep 2025
SOZO Pro
K232089 · ImpediMed Limited · Oct 2023
Zynex Monitoring System, Model CM-1600
K223217 · Zynex Medical, Inc. · Jun 2023