Cleared Traditional

Hypodermic Syringes & Needle (K222925) - FDA 510(k) Clearance

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

K222925 · Lifelong Meditech Private Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
295d
Days
Class 2
Risk

K222925 is an FDA 510(k) clearance for the Hypodermic Syringes & Needle. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Lifelong Meditech Private Limited (Gurgaon, IN). The FDA issued a Cleared decision on July 18, 2023 after a review of 295 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 Lifelong Meditech Private Limited devices

Submission Details

510(k) Number K222925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2022
Decision Date July 18, 2023
Days to Decision 295 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
166d slower than avg
Panel avg: 129d · This submission: 295d
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 Consultant

Alceon
Atonu Dutta

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMF Syringe, Piston

All 241
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K222925.
BD Texium™ Needle-Free Syringe
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Sterile Auto-Disable Syringes with/without Needle for Single Use
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A-TAP (previously called Arthrotap)
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Avitus® DragonWing Large Volume Autograft Delivery System
K231456 · Avitus Orthopaedics, Inc. · Jul 2023
Avitus® Precision Autograft Delivery System
K230492 · Avitus Orthopaedics, Inc. · Jun 2023
Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use
K212857 · Jiangsu Zhiyu Medical Instrument Co, Ltd. · May 2023