Cleared Traditional

Insulin Syringe (K233794) - FDA 510(k) Clearance

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

K233794 · Spm Medicare Pvt. , Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Mar 2024
Decision
99d
Days
Class 2
Risk

K233794 is an FDA 510(k) clearance for the Insulin Syringe. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Spm Medicare Pvt. , Ltd. (Noida, IN). The FDA issued a Cleared decision on March 6, 2024 after a review of 99 days - within the typical 510(k) review window.

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 Spm Medicare Pvt. , Ltd. devices

Submission Details

510(k) Number K233794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2023
Decision Date March 06, 2024
Days to Decision 99 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 129d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Regulatory Technology Services, LLC
Prithul Bom

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 239
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K233794.
Pen Injector
K240774 · Wuxi Nest Biotechnology Co., Ltd. · Jun 2024
Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle
K232950 · Perfect Medical Industry (Vn) Co., Ltd. · Jun 2024
HWJECT Auto-disable syringe
K234024 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Mar 2024
Medline Luer Lock Syringes
K230235 · Medline Industries, LP · Feb 2024
SMB Luer lock disposable syringe
K231558 · Smb Corporation of India · Jan 2024
Insulin Syringe
K230061 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Nov 2023

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.