Cleared Traditional

K953089 - I-SPOUSE

K953089 is an FDA 510(k) clearance for I-SPOUSE, manufactured by Products For Medicine. The device is a Class 1 General Hospital device with product code LYU cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K953089 · Products For Medicine · General Hospital
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Oct 1995
Decision
105d
Days
Class 1
Risk

K953089 is an FDA 510(k) clearance for the I-SPOUSE. Classified as Accessory, Surgical Apparel (product code LYU), Class I - General Controls.

Submitted by Products For Medicine (Irvine, US). The FDA issued a Cleared decision on October 16, 1995 after a review of 105 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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 Products For Medicine devices

FDA 510(k) Submission Details - K953089

510(k) Number K953089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1995
Decision Date October 16, 1995
Days to Decision 105 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 129d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

LYU Device Classification - Class 1, General Controls

Product Code LYU Accessory, Surgical Apparel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LYU Accessory, Surgical Apparel

All 10
Devices cleared under the same product code (LYU) and FDA review panel - the closest regulatory comparables to K953089.
STRYKER T4 HYTREL (R) TOGAS
K011755 · Stryker Corp. · Jun 2001
DISPOSABLE APRON
K964364 · Instrument Makar, Inc. · Feb 1997
DEPUY DISPOSABLE FILTER/HOOD
K961791 · Depuy, Inc. · Aug 1996
MAKAR FULL AND HALF FACE SHIELD
K942828 · Instrument Makar, Inc. · Feb 1995
FACE-IT SHIELD
K942022 · Onyx Medical Corp. · Jul 1994
PROCEL(TM) DERMALINER GLOVE
K931094 · W.L. Gore & Associates, Inc. · Feb 1994