Cleared Traditional

K061197 - KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER

K061197 is an FDA 510(k) clearance for KAWASUMI LABORATORIES EMPTY SOLUTION CO..., manufactured by Kawasumi Laboratories, Inc.. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K061197 · Kawasumi Laboratories, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
63d
Days
Class 2
Risk

K061197 is an FDA 510(k) clearance for the KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Kawasumi Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on June 30, 2006 after a review of 63 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5025 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K061197

510(k) Number K061197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2006
Decision Date June 30, 2006
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPE Device Classification - Class 2, Special Controls

Product Code KPE Container, I.v.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5025
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 - KPE Container, I.v.

All 116
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K061197.
EVA TPN BAG
K101412 · Valmed S.R.L. · Apr 2011
ALL-IN-ONE CONTAINER
K090096 · Baxter Healthcare Corporation · Jan 2009
DUAL CHAMBER TPN CONTAINER
K073538 · B.Braun Medical, Inc. · Mar 2008
CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
K041038 · Churchill Medical Systems, Inc. · Dec 2004
EVA TPN CONTAINER
K041415 · B.Braun Medical, Inc. · Aug 2004
GRI-BAG, GRI-BAG AP
K033916 · Laboratorios Grifols, S.A. · Dec 2003
K061197 · KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER
Download PDF FDA Summary Kawasumi Laboratories…