Cleared Traditional

K213054 - Medline Sure-Snap Safety Needle

K213054 is the FDA 510(k) clearance for Medline Sure-Snap Safety Needle by Medline Industries, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 443-day FDA review.

K213054 · Medline Industries, Inc. · General Hospital
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Dec 2022
Decision
443d
Days
Class 2
Risk

K213054 is an FDA 510(k) clearance for the Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on December 9, 2022 after a review of 443 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K213054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2021
Decision Date December 09, 2022
Days to Decision 443 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
314d slower than avg
Panel avg: 129d · This submission: 443d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 285
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K213054.
Sofjec
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Insulin syringe with integrated needle DL
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Sterile Syringes for Single Use
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Medwell Technology Ltd Syringes, various sizes
K212764 · Medwell Technology, Ltd. · Nov 2022
Insulin Syringes without needle
K221045 · Berpu Medical Technology Co., Ltd. · Nov 2022
Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle
K221308 · Jiangxi Maidikang Medical Devices Co., Ltd. · Oct 2022