Cleared Traditional

K861012 - SILENT PARTNER MODEL 10-1001

K861012 is an FDA 510(k) clearance for SILENT PARTNER MODEL 10-1001, manufactured by Medical Devices, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K861012 · Medical Devices, Inc. · Anesthesiology device
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Apr 1986
Decision
17d
Days
Class 2
Risk

K861012 is an FDA 510(k) clearance for the SILENT PARTNER MODEL 10-1001. Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Medical Devices, Inc. (Ontario M3h 5t5, CA). The FDA issued a Cleared decision on April 4, 1986 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medical Devices, Inc. devices

FDA 510(k) Submission Details - K861012

510(k) Number K861012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1986
Decision Date April 04, 1986
Days to Decision 17 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 140d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAW Device Classification - Class 2, Special Controls

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
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 - CAW Generator, Oxygen, Portable

All 89
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K861012.
H-3000 OXYGEN CONCENTRATOR
K890150 · Healthdyne, Inc. · Jan 1989
CRITERION II & IIA OXYGEN CONCENTRATORS
K871603 · Timeter Instrument Corp. · Aug 1987
SILENT PARTNER MODEL 10-2001
K861011 · Medical Devices, Inc. · Apr 1986
OXYGEN CONCENTRATOR, MODEL BX-5000
K854374 · Healthdyne, Inc. · Jan 1986
MOBILAIRE III P3 OXYGEN CONCENTRATOR
K851434 · Invacare Corp. · Jul 1985
PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR
K851435 · Invacare Corp. · Jul 1985