Cleared Traditional

K211204 - SafePort(TM) Manifold (or Stopcock) (FDA 510(k) Clearance)

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

K211204 · Elcam Medical Acal · General Hospital
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Sep 2022
Decision
511d
Days
Class 2
Risk

K211204 is an FDA 510(k) clearance for the SafePort(TM) Manifold (or Stopcock). Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Elcam Medical Acal (Baram, IL). The FDA issued a Cleared decision on September 15, 2022 after a review of 511 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Elcam Medical Acal devices

Submission Details

510(k) Number K211204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2021
Decision Date September 15, 2022
Days to Decision 511 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
383d slower than avg
Panel avg: 128d · This submission: 511d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMG Stopcock, I.v. Set
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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.