Cleared Traditional

K931095 - SPRING LOADED SYRINGE

K931095 is the FDA 510(k) clearance for SPRING LOADED SYRINGE by Acacia, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K931095 · Acacia, Inc. · General Hospital
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Sep 1993
Decision
197d
Days
Class 2
Risk

K931095 is an FDA 510(k) clearance for the SPRING LOADED SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Acacia, Inc. (Ojai, US). The FDA issued a Cleared decision on September 16, 1993 after a review of 197 days - an extended review cycle.

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 Acacia, Inc. devices

Submission Details

510(k) Number K931095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1993
Decision Date September 16, 1993
Days to Decision 197 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 129d · This submission: 197d
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 264
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K931095.
BD MICRO FINE, ULTRA FINE, AND ALLERGY SYRINGE
K941657 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994
ADVANTAGE SYRINGE
K941545 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994
ONE TIME VIAL ACCESS SPIKE
K934561 · Icu Medical, Inc. · Feb 1994
MONOJECT(R) 6 CC SAFETY SYRINGE
K924511 · Sherwood Medical Co. · Jul 1993
FIBRACOL COLLAGEN-ALGINATE DRESSING
K925548 · Johnson & Johnson Medical, Inc. · Jul 1993
ARGYLE TURKEL SAFETY THORACENTESIS PROC. TRAY
K930847 · Sherwood Medical Co. · Jul 1993