Cleared Traditional

K930847 - ARGYLE TURKEL SAFETY THORACENTESIS PROC...

K930847 is the FDA 510(k) clearance for ARGYLE TURKEL SAFETY THORACENTESIS PROC... by Sherwood Medical Co.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K930847 · Sherwood Medical Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
144d
Days
Class 2
Risk

K930847 is an FDA 510(k) clearance for the ARGYLE TURKEL SAFETY THORACENTESIS PROC. TRAY. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on July 12, 1993 after a review of 144 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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.

View all Sherwood Medical Co. devices

Submission Details

510(k) Number K930847 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received February 18, 1993
Decision Date July 12, 1993
Days to Decision 144 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
15d slower than avg
Panel avg: 129d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 285
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K930847.
ONE TIME VIAL ACCESS SPIKE
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K930321 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1993
BECTON DICKINSON ARTERIAL BLOOD GAS KITS
K930342 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1993
BECTON DICKINSON SAFETY-LOK SYRINGE
K924072 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1992