Cleared Traditional

MONOPLACE HYPERBARIC EXTENSION SET (L 11055) (K884141) - FDA 510(k) Clearance

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

K884141 · Abbott Laboratories · General Hospital
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Feb 1989
Decision
151d
Days
Class 2
Risk

K884141 is an FDA 510(k) clearance for the MONOPLACE HYPERBARIC EXTENSION SET (L 11055). Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 28, 1989 after a review of 151 days - an extended review cycle.

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. 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 Abbott Laboratories devices

Submission Details

510(k) Number K884141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1988
Decision Date February 28, 1989
Days to Decision 151 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 129d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 237
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K884141.
TERUMO SURFLO(R) INJECTION PLUG
K891146 · Terumo Medical Corp. · Jun 1989
EXTENSION SET W/FLOW REGULATOR
K890489 · Baxter Healthcare Corp · Jun 1989
LOW ADSORPTION ADMINISTRATION SET
K885031 · 3M Company · May 1989
MODIFIED 7 INCH CONTINUOUS INFUSION SETS
K884102 · Quinton, Inc. · Jan 1989
STANDARD ADMINISTRATION SETS
K885030 · 3M Company · Jan 1989
SAFESITE INJECTION SITE AND BLUNT CANNULA
K883638 · Baxter Healthcare Corp · Sep 1988