Cleared Traditional

K831797 - HEMOSTATS

K831797 is an FDA 510(k) clearance for HEMOSTATS, manufactured by I M, Inc.. The device is a Class 1 General & Plastic Surgery device with product code HRQ cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K831797 · I M, Inc. · General & Plastic Surgery device
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Jul 1983
Decision
46d
Days
Class 1
Risk

K831797 is an FDA 510(k) clearance for the HEMOSTATS. Classified as Hemostat (product code HRQ), Class I - General Controls.

Submitted by I M, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 19, 1983 after a review of 46 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.

View all I M, Inc. devices

FDA 510(k) Submission Details - K831797

510(k) Number K831797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1983
Decision Date July 19, 1983
Days to Decision 46 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
69d faster than avg
Panel avg: 115d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

HRQ Device Classification - Class 1, General Controls

Product Code HRQ Hemostat
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 - HRQ Hemostat

All 9
Devices cleared under the same product code (HRQ) and FDA review panel - the closest regulatory comparables to K831797.
HEMSTATS
K844152 · I M, Inc. · Nov 1984
SCANLAN VASCU-STATT II APPROXIMATOR
K841514 · Scanlan Intl., Inc. · Jun 1984
OP-CON SURG. INSTRUMENTS #11
K834175 · Imm Enterprises , Ltd. · Jan 1984
VASCU-STATT APPROXIMATOR
K823694 · Scanlan Intl., Inc. · Jan 1983
VARIOUS TYPES OF TONSILS HEMOSTATS
K822263 · Kelleher Corp. · Aug 1982
SCANLAN SUTURE-STATT
K821887 · Scanlan Intl., Inc. · Jul 1982