Cleared Traditional

TrueCare Biomedix Tamper Evident Cap (K210818) - FDA 510(k) Clearance

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

K210818 · Us Infusion Inc. D/B/A Truecare Biomedix-USA · General Hospital
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Sep 2021
Decision
181d
Days
Class 2
Risk

K210818 is an FDA 510(k) clearance for the TrueCare Biomedix Tamper Evident Cap. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Us Infusion Inc. D/B/A Truecare Biomedix-USA (South Miami, US). The FDA issued a Cleared decision on September 15, 2021 after a review of 181 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 Us Infusion Inc. D/B/A Truecare Biomedix-USA devices

Submission Details

510(k) Number K210818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2021
Decision Date September 15, 2021
Days to Decision 181 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
52d slower than avg
Panel avg: 129d · This submission: 181d
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 K210818.
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