Cleared Special

K002434 - PALM PUMP

K002434 is an FDA 510(k) clearance for PALM PUMP, manufactured by Sorenson Medical, Inc.. The device is a Class 2 General Hospital device with product code MEA cleared through the Special 510(k) pathway after a 14-day FDA review.

K002434 · Sorenson Medical, Inc. · General Hospital
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Aug 2000
Decision
14d
Days
Class 2
Risk

K002434 is an FDA 510(k) clearance for the PALM PUMP. Classified as Pump, Infusion, Pca (product code MEA), Class II - Special Controls.

Submitted by Sorenson Medical, Inc. (West Jordan, US). The FDA issued a Cleared decision on August 23, 2000 after a review of 14 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K002434

510(k) Number K002434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2000
Decision Date August 23, 2000
Days to Decision 14 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

MEA Device Classification - Class 2, Special Controls

Product Code MEA Pump, Infusion, Pca
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 General Hospital devices follow this clearance model.

Regulatory Peers - MEA Pump, Infusion, Pca

All 30
Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K002434.
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
K022203 · Abbott Laboratories · Aug 2002
MICROJET CRONO PCA
K013822 · Cane S.R.L. · May 2002
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
K002739 · Baxter Healthcare Corp · Sep 2000
AVIA PAIN MEDICATION DELIVERY SYSTEM
K990312 · Amtec Medical · Apr 1999
CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300
K982839 · Sims Deltec, Inc. · Nov 1998
MODEL 6100 AMBULATORY INFUSION SYSTEM
K943310 · Pharmacia Deltec, Inc. · Feb 1995
K002434 · PALM PUMP
Download PDF Sorenson Medical, Inc.