Cleared Traditional

K883485 - STRYKER PRESSURE MONITOR SYSTEM

K883485 is an FDA 510(k) clearance for STRYKER PRESSURE MONITOR SYSTEM, manufactured by Stryker Corp.. The device is a Class 1 General & Plastic Surgery device with product code FTY cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K883485 · Stryker Corp. · General & Plastic Surgery device
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Sep 1988
Decision
28d
Days
Class 1
Risk

K883485 is an FDA 510(k) clearance for the STRYKER PRESSURE MONITOR SYSTEM. Classified as Tape, Measuring, Rulers And Calipers (product code FTY), Class I - General Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on September 13, 1988 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 - K883485

510(k) Number K883485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1988
Decision Date September 13, 1988
Days to Decision 28 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

FTY Device Classification - Class 1, General Controls

Product Code FTY Tape, Measuring, Rulers And Calipers
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - FTY Tape, Measuring, Rulers And Calipers

All 22
Devices cleared under the same product code (FTY) and FDA review panel - the closest regulatory comparables to K883485.
DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC
K951064 · S-E Sales & Distribution, Inc. · May 1995
OLYMPIC AUTO-LENGTH
K934930 · Olympic Medical Corp. · Dec 1993
OLYMPIC INFA-LENGTH
K932112 · Olympic Medical Corp. · Jul 1993
PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S.
K880441 · Plane Iii, Inc. · Feb 1988
TUMORIMETER
K874352 · Cancer Technologies, Inc. · Nov 1987
TEMPLATE
K873470 · Cox-Uphuff Intl. · Sep 1987
K883485 · STRYKER PRESSURE MONITOR SYSTEM
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