Cleared Traditional

K940832 - I.V. ADMINISTRATION SET CONNECTING DEVICE

K940832 is an FDA 510(k) clearance for I.V. ADMINISTRATION SET CONNECTING DEVICE, manufactured by Sierra Medical Devices. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 699-day FDA review.

K940832 · Sierra Medical Devices · General Hospital
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Jan 1996
Decision
699d
Days
Class 2
Risk

K940832 is an FDA 510(k) clearance for the I.V. ADMINISTRATION SET CONNECTING DEVICE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Sierra Medical Devices (Grass Valley, US). The FDA issued a Cleared decision on January 23, 1996 after a review of 699 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 Sierra Medical Devices devices

FDA 510(k) Submission Details - K940832

510(k) Number K940832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1994
Decision Date January 23, 1996
Days to Decision 699 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
570d slower than avg
Panel avg: 129d · This submission: 699d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
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.

Regulatory Peers - FPA Set, Administration, Intravascular

All 749
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K940832.
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K953746 · Arrow Intl., Inc. · Jan 1996
EXTENSION SET WITH CHECK VALVE
K954983 · Distronic Sterile Products, Inc. · Jan 1996
SIMS DELTEC ANTI-SIPHON VALVE
K954870 · Sims Deltec, Inc. · Dec 1995
ICU EXTENSION KIT
K954813 · Icu Medical, Inc. · Nov 1995