Cleared Traditional

K930854 - SOLUTION SET WITH .2 MICRON FILTER

K930854 is an FDA 510(k) clearance for SOLUTION SET WITH .2 MICRON FILTER, manufactured by Douglas Medical Products Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K930854 · Douglas Medical Products Corp. · General Hospital
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Jan 1994
Decision
330d
Days
Class 2
Risk

K930854 is an FDA 510(k) clearance for the SOLUTION SET WITH .2 MICRON FILTER. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Douglas Medical Products Corp. (Mundelein, US). The FDA issued a Cleared decision on January 14, 1994 after a review of 330 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Douglas Medical Products Corp. devices

FDA 510(k) Submission Details - K930854

510(k) Number K930854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1993
Decision Date January 14, 1994
Days to Decision 330 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
201d slower than avg
Panel avg: 129d · This submission: 330d
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 571
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K930854.
SAFE CONNECTOR
K940296 · Icu Medical, Inc. · Feb 1994
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K933390 · Pharmacia Deltec, Inc. · Feb 1994
0.22 MICRON FINAL FILTER WITH EXTENSION TUBE
K935601 · Puritas Health Care, Inc. · Jan 1994
EZ ADMINISTRATION SET
K931550 · Y · Jan 1994
3 LEAD CONNECTOR
K931659 · Douglas Medical Products Corp. · Jan 1994
SUBCUTANEOUS INFUSION SET
K932637 · Douglas Medical Products Corp. · Jan 1994