Cleared Traditional

K921295 - INTRAVENOUS CATHETERS MODIFICATIONS

K921295 is an FDA 510(k) clearance for INTRAVENOUS CATHETERS MODIFICATIONS, manufactured by Critikon Company, LLC. The device is a Class 2 Gastroenterology & Urology device with product code FGO cleared through the Traditional 510(k) pathway after a 431-day FDA review.

K921295 · Critikon Company, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
431d
Days
Class 2
Risk

K921295 is an FDA 510(k) clearance for the INTRAVENOUS CATHETERS MODIFICATIONS. Classified as Dislodger, Stone, Flexible (product code FGO), Class II - Special Controls.

Submitted by Critikon Company, LLC (Tampa, US). The FDA issued a Cleared decision on May 17, 1993 after a review of 431 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4680 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Critikon Company, LLC devices

FDA 510(k) Submission Details - K921295

510(k) Number K921295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1992
Decision Date May 17, 1993
Days to Decision 431 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
301d slower than avg
Panel avg: 130d · This submission: 431d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGO Device Classification - Class 2, Special Controls

Product Code FGO Dislodger, Stone, Flexible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4680
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 - FGO Dislodger, Stone, Flexible

All 12
Devices cleared under the same product code (FGO) and FDA review panel - the closest regulatory comparables to K921295.
STONE DISLODGER, BASKET
K951309 · Boston Scientific Corp · May 1995
GRASPING FORCEPS
K933261 · Surgitek · Jan 1994
GRASPING FORCEPS OR RETRIEVAL FORCEPS
K934598 · Annex Medical, Inc. · Jan 1994
GRASPING FORCEPS
K922542 · Surgitek · Aug 1992
GRASPING FORCEPS
K914110 · Annex Medical, Inc. · Feb 1992
METAL URETERAL BASKET STONE DISLODGER, HELICAL
K914111 · Annex Medical, Inc. · Feb 1992