Cleared Traditional

K011865 - ZOLL M SERIES IBP OPERATION

Also marketed or referenced as:
ZOLL M SERIES TEMPERATURE OPTION

K011865 is an FDA 510(k) clearance for ZOLL M SERIES IBP OPERATION, manufactured by Zoll Medical Corp. The device is a Class 2 Cardiovascular device with product code DSK cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K011865 · Zoll Medical Corp · Cardiovascular device
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Jul 2001
Decision
47d
Days
Class 2
Risk

K011865 is an FDA 510(k) clearance for the ZOLL M SERIES IBP OPERATION. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Zoll Medical Corp (Burlington, US). The FDA issued a Cleared decision on July 31, 2001 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - the FDA cardiovascular device 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zoll Medical Corp devices

FDA 510(k) Submission Details - K011865

510(k) Number K011865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2001
Decision Date July 31, 2001
Days to Decision 47 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 125d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSK Device Classification - Class 2, Special Controls

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DSK Computer, Blood-pressure

All 51
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K011865.
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K013943 · Radi Medical Systems AB · Dec 2001
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K002067 · Radi Medical Systems AB · Jan 2001
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