Cleared Traditional

Insulin syringe with integrated needle DL (K203211) - FDA 510(k) Clearance

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

K203211 · Dlp Medical Products, Corp. · General Hospital
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Feb 2023
Decision
832d
Days
Class 2
Risk

K203211 is an FDA 510(k) clearance for the Insulin syringe with integrated needle DL. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Dlp Medical Products, Corp. (San Antonio, US). The FDA issued a Cleared decision on February 9, 2023 after a review of 832 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 Dlp Medical Products, Corp. devices

Submission Details

510(k) Number K203211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2020
Decision Date February 09, 2023
Days to Decision 832 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
703d slower than avg
Panel avg: 129d · This submission: 832d
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 241
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K203211.
Insulin Syringe
K223453 · Promisemed Hangzhou Meditech Co., Ltd. · Mar 2023
CompuFlo Epidural Computer Controlled Anesthesia System
K221702 · Milestone Scientific, Inc. · Feb 2023
Sofjec
K212635 · Hwajin Medical Co., Ltd. · Feb 2023
Sterile Syringes for Single Use
K223678 · Shanghai Kindly Enterprise Development Group Co., Ltd. · Feb 2023
Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
K213054 · Medline Industries, Inc. · Dec 2022
Medwell Technology Ltd Syringes, various sizes
K212764 · Medwell Technology, Ltd. · Nov 2022