Cleared Traditional

K931819 - CARAPACE SUTURE REMOVAL TRAYS

K931819 is an FDA 510(k) clearance for CARAPACE SUTURE REMOVAL TRAYS, manufactured by Carapace, Inc.. The device is a Class 1 Physical Medicine device with product code IRO cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K931819 · Carapace, Inc. · Physical Medicine device
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Jan 1994
Decision
293d
Days
Class 1
Risk

K931819 is an FDA 510(k) clearance for the CARAPACE SUTURE REMOVAL TRAYS. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Carapace, Inc. (Broken Arrow, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 293 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5975 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Carapace, Inc. devices

FDA 510(k) Submission Details - K931819

510(k) Number K931819 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received April 08, 1993
Decision Date January 26, 1994
Days to Decision 293 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 115d · This submission: 293d
Pathway characteristics
Predicate-based equivalence.

IRO Device Classification - Class 1, General Controls

Product Code IRO Vibrator, Therapeutic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5975
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 - IRO Vibrator, Therapeutic

All 19
Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K931819.
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SONASSAGE
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HEALTLH ESSENTIALS PERSONAL MASSAGER
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BODYTHERM
K924519 · Conair Corp. · Oct 1993
HEALTH ESSENTIALS MAXI MASSAGER
K924581 · Conair Corp. · Oct 1993