Cleared Traditional

K001342 - P.O.P. PAIN KIT

K001342 is an FDA 510(k) clearance for P.O.P. PAIN KIT, manufactured by Post Operative Pain Management. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K001342 · Post Operative Pain Management · General Hospital
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Sep 2000
Decision
133d
Days
Class 2
Risk

K001342 is an FDA 510(k) clearance for the P.O.P. PAIN KIT. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Post Operative Pain Management (Broadview Heights, US). The FDA issued a Cleared decision on September 7, 2000 after a review of 133 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Post Operative Pain Management devices

FDA 510(k) Submission Details - K001342

510(k) Number K001342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2000
Decision Date September 07, 2000
Days to Decision 133 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 129d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEB Device Classification - Class 2, Special Controls

Product Code MEB Pump, Infusion, Elastomeric
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 - MEB Pump, Infusion, Elastomeric

All 59
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K001342.
PAIN CARE 3200
K013928 · Breg, Inc. · Dec 2001
MULTIRATE INFUSOR SV
K011317 · Baxter Healthcare Corp · Jun 2001
PAIN CARE 3000
K002073 · Breg, Inc. · Sep 2000
PAIN CARE 2000L
K002321 · Breg, Inc. · Aug 2000
AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10
K993832 · Tandem Medical, Inc. · Feb 2000
DISPOSABLE INFUSION PUMP KIT
K993972 · Biomet, Inc. · Feb 2000