Cleared Traditional

K931095 - SPRING LOADED SYRINGE

K931095 is an FDA 510(k) clearance for SPRING LOADED SYRINGE, manufactured by Acacia, Inc.. The device is a Class 2 General Hospital device with 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.

FDA 510(k) Submission Details - K931095

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
Combination Product No
PCCP Authorized No
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.

FMF Device Classification - Class 2, Special Controls

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 706
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K931095.
ALLISON MEDICAL SYRINGE
K932001 · Allison Medical, Inc. · Jan 1994
BASIC SKIN PREP TRAY
K932361 · Mcbar Industries · Dec 1993
EDGE SYRINGES AND NEEDLES
K923321 · Trico Intl., Inc. · Sep 1993
I.D.A. SYRINGES
K931632 · Pt Hasoon Chandra · Aug 1993
AMERICAN POWER CONVERSIONS, BACK-UPS 600
K930791 · Bio Clinic Co. · Aug 1993
MONOJECT(R) 6 CC SAFETY SYRINGE
K924511 · Sherwood Medical Co. · Jul 1993
K931095 · SPRING LOADED SYRINGE
Download PDF Acacia, Inc.