Cleared Traditional

K853120 - ADDITIVE EXTENSION SYRINGE

K853120 is an FDA 510(k) clearance for ADDITIVE EXTENSION SYRINGE, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K853120 · Abbott Laboratories · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1985
Decision
133d
Days
Class 2
Risk

K853120 is an FDA 510(k) clearance for the ADDITIVE EXTENSION SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 5, 1985 after a review of 133 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K853120

510(k) Number K853120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1985
Decision Date December 05, 1985
Days to Decision 133 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 129d · This submission: 133d
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 329
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K853120.
MONOJECT PHARMACY TRAY
K860688 · Sherwood Medical Co. · Aug 1987
SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT
K870518 · Surgitek · Apr 1987
VARIOUS SYRINGES W/NEEDLES, W/OUT NEEDLES, NEEDLES
K864747 · Jms Co., Ltd. · Dec 1986
JMS LCC INSULIN SYRINGE
K853838 · Jms Co., Ltd. · Oct 1985
MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES
K852544 · Sherwood Medical Co. · Jul 1985
MONOJECT STERILE 60CC SYRINGES
K852580 · Sherwood Medical Co. · Jul 1985