Cleared Traditional

OTTER SAFETY SYRINGE (K040545) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K040545 · Otter (China) Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
51d
Days
Class 2
Risk

K040545 is an FDA 510(k) clearance for the OTTER SAFETY SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Otter (China) Technology Co., Ltd. (Stillwater, US). The FDA issued a Cleared decision on April 22, 2004 after a review of 51 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Otter (China) Technology Co., Ltd. devices

Submission Details

510(k) Number K040545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2004
Decision Date April 22, 2004
Days to Decision 51 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 129d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEG Syringe, Antistick
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 - MEG Syringe, Antistick

All 37
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K040545.
Greenmedi Safety Filter Syringe
K173743 · Sang-A Frontec Co., Ltd. · Jan 2019
Self-destruction Safety Syringes for Single Use
K180417 · Berpu Medical Technology Co., Ltd. · Aug 2018
MEDLINE RETRACTABLE SAFETY SYRINGE
K101560 · Medline Industries, Inc. · Mar 2011
BECTON DICKINSON SYRINGE
K992734 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1999
HYPO(R) SAFETY CARTRIDGE SYRINGE
K936040 · Smith & Nephew, Inc. · May 1995