Cleared Traditional

K964541 - SANPO I

K964541 is an FDA 510(k) clearance for SANPO I, manufactured by Koike Medical Co.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K964541 · Koike Medical Co. · Anesthesiology device
Download Printable Device Report (PDF)
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Sep 1997
Decision
329d
Days
Class 2
Risk

K964541 is an FDA 510(k) clearance for the SANPO I. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Koike Medical Co. (Washington, US). The FDA issued a Cleared decision on September 26, 1997 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Koike Medical Co. devices

FDA 510(k) Submission Details - K964541

510(k) Number K964541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1996
Decision Date September 26, 1997
Days to Decision 329 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 140d · This submission: 329d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFB Device Classification - Class 2, Special Controls

Product Code NFB Conserver, Oxygen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - NFB Conserver, Oxygen

All 35
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K964541.
IMPULSE SELECT
K001579 · Airsep Corp. · Aug 2000
CHAD THERAPEUTICS OXYMATIC MODEL 401
K000890 · Chad Therapeutics, Inc. · Jun 2000
PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)
K990678 · Salter Labs · May 1999
FLOTEC OXYSAVRR (S)
K970371 · Flotec, Inc. · Jul 1997
PULSE DOSE SERIES
K961126 · Devilbiss Health Care, Inc. · Oct 1996
AIRSEP IMPULSE
K962766 · Airsep Corp. · Oct 1996