Cleared Traditional

K041714 - E-PAIN CARE

K041714 is an FDA 510(k) clearance for E-PAIN CARE, manufactured by Breg, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K041714 · Breg, Inc. · General Hospital
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Oct 2004
Decision
100d
Days
Class 2
Risk

K041714 is an FDA 510(k) clearance for the E-PAIN CARE. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Breg, Inc. (Vista, US). The FDA issued a Cleared decision on October 1, 2004 after a review of 100 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 Breg, Inc. devices

FDA 510(k) Submission Details - K041714

510(k) Number K041714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2004
Decision Date October 01, 2004
Days to Decision 100 days
Submission Type Traditional
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
29d faster than avg
Panel avg: 129d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
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 - FRN Pump, Infusion

All 582
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K041714.
BEELINE MOTIV, PROPOLIS, PCA
K042228 · Mckinley, Inc. · Nov 2004
PAINPUMP1
K042405 · Stryker Corp. · Oct 2004
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
K042609 · Hospira, Inc. · Oct 2004
CRONO F
K042085 · Cane S.R.L. · Sep 2004
SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY
K042121 · Sigma Intl. · Aug 2004
PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K042081 · Hospira, Inc. · Aug 2004