Cleared Traditional

K936040 - HYPO(R) SAFETY CARTRIDGE SYRINGE (FDA 510(k) Clearance)

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

K936040 · Smith & Nephew, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
497d
Days
Class 2
Risk

K936040 is an FDA 510(k) clearance for the HYPO(R) SAFETY CARTRIDGE SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Franklin Park, US). The FDA issued a Cleared decision on May 1, 1995 after a review of 497 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K936040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1993
Decision Date May 01, 1995
Days to Decision 497 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
369d slower than avg
Panel avg: 128d · This submission: 497d
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 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K936040.
PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)
K252098 · Methyl Co., Ltd. · Feb 2026
VaporShield
K250847 · Vault Paragon Group, Inc. · Dec 2025
Shina Syringe
K231165 · Shina Med Corporation · Oct 2023
Medline Safety Insulin and TB Syringes
K231907 · Medline Industries, LP · Oct 2023
Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110)
K223376 · Cardinal Health200, LLC · Jun 2023