Cleared Traditional

INMAN MEDICAL PACKING STRIP (K921291) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K921291 · Inman Medical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
316d
Days
Class 2
Risk

K921291 is an FDA 510(k) clearance for the INMAN MEDICAL PACKING STRIP. Classified as Anoscope And Accessories (product code FER), Class II - Special Controls.

Submitted by Inman Medical Corp. (Fort Worth, US). The FDA issued a Cleared decision on January 21, 1993 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Inman Medical Corp. devices

Submission Details

510(k) Number K921291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1992
Decision Date January 21, 1993
Days to Decision 316 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 130d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FER Anoscope And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Anus And Rectum.
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FER Anoscope And Accessories

All 26
Devices cleared under the same product code (FER) and FDA review panel - the closest regulatory comparables to K921291.
SleeveLUX 24 Anoscope/Proctoscope (P2001)
K250645 · Haemoband Surgical, Ltd. · Oct 2025
Gastro Concepts Air Assist
K242668 · Gastro Concepts, LLC · Dec 2024
WellCare Anoscope
K230439 · Well Care (Wuhan) Medical Technology Co., Ltd. · Dec 2023
Applied Medical Anoscope
K200021 · Applied Medical Resources · Jan 2021
ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL
K881469 · Baxter Healthcare Corp · Sep 1988