Cleared Traditional

K921026 - PRESSURE GAUGE

K921026 is the FDA 510(k) clearance for PRESSURE GAUGE by Hobbs Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K921026 · Hobbs Medical, Inc. · Gastroenterology & Urology device
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Apr 1992
Decision
52d
Days
Class 2
Risk

K921026 is an FDA 510(k) clearance for the PRESSURE GAUGE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Hobbs Medical, Inc. (Stafford Springs, US). The FDA issued a Cleared decision on April 24, 1992 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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: 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 Hobbs Medical, Inc. devices

Submission Details

510(k) Number K921026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1992
Decision Date April 24, 1992
Days to Decision 52 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
78d faster than avg
Panel avg: 130d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 253
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K921026.
LOW PROFILE GASTROMSTOMY DEVICE
K923474 · Biosearch Medical Products, Inc. · Jan 1993
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K921697 · Abbott Laboratories · Aug 1992
FLEXIFLO QUANTUM ENT. PUMP SETS AND ENT. NUT. CONT
K915735 · Abbott Laboratories · Jun 1992
FLEXIFLO OVER-THE-GUIDEWIRE GASTROSTOMY KIT
K915110 · Abbott Laboratories · Apr 1992
SAECG CARDIOGRAPH MODEL M1754A
K913997 · Hewlett-Packard Co. · Mar 1992
NON-WEIGHTED POLYURETHANE ENTERAL FEEDING TUBE
K914375 · Sherwood Medical Co. · Mar 1992