Cleared Traditional

K212677 - aboNT SYRINGE

K212677 is an FDA 510(k) clearance for aboNT SYRINGE, manufactured by Nipro Medical Corporation. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K212677 · Nipro Medical Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
234d
Days
Class 2
Risk

K212677 is an FDA 510(k) clearance for the aboNT SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on April 15, 2022 after a review of 234 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 Nipro Medical Corporation devices

FDA 510(k) Submission Details - K212677

510(k) Number K212677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2021
Decision Date April 15, 2022
Days to Decision 234 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
105d slower than avg
Panel avg: 129d · This submission: 234d
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 484
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K212677.
Pump Alignment Syringe
K220184 · Jiangsu Caina Medical Co.,Ltd · Jul 2022
Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle
K220204 · Anhui Tiankang Medical Technology Co., Ltd. · Jul 2022
Sterile Hypodermic Syringes for Single Use
K213811 · Berpu Medical Technology Co., Ltd. · May 2022
Verifine Safety Syringe with Fixed Needle
K213560 · Promisemed Hangzhou Meditech Co., Ltd. · Apr 2022
Qitexio
K203738 · Medex · Mar 2022
Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use
K212920 · Shandong Weigao Group Medical Polymer Co., Ltd. · Mar 2022