Cleared Traditional

K951119 - NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM

K951119 is an FDA 510(k) clearance for NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM, manufactured by American Hydro-Surgical Instruments, Inc.. The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K951119 · American Hydro-Surgical Instruments, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
95d
Days
Class 2
Risk

K951119 is an FDA 510(k) clearance for the NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by American Hydro-Surgical Instruments, Inc. (Delray Beach, US). The FDA issued a Cleared decision on June 13, 1995 after a review of 95 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K951119

510(k) Number K951119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1995
Decision Date June 13, 1995
Days to Decision 95 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 129d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCX Device Classification - Class 2, Special Controls

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 General Hospital devices follow this clearance model.

Regulatory Peers - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 65
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K951119.
MEDCARE YANKAUER SUCTION DEVICE
K954869 · Medcare Custom Packaging, Inc. · Jan 1996
STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)
K954726 · Stryker Endoscopy · Nov 1995
SUCTION TIP CLEANER CUP
K952219 · Moore/Gobel · Nov 1995
SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT VEHICLES
K950464 · Sscor · Apr 1995
INAMED DEVELOPMENT ASPIRATION TIP
K931548 · Inamed Development Co. · Jan 1994
OEM MULTI-VAC POWERED SUCTION PUMP
K924570 · Oem Medical Div. · Aug 1993
K951119 · NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM
Download PDF FDA Summary American Hydro-Surgic…