Cleared Traditional

K884141 - MONOPLACE HYPERBARIC EXTENSION SET (L 1...

K884141 is an FDA 510(k) clearance for MONOPLACE HYPERBARIC EXTENSION SET (L 1..., manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K884141 · Abbott Laboratories · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K884141

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.

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 532
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
CRIS ADAPTER
K883986 · Y · Feb 1989
MODIFIED 7 INCH CONTINUOUS INFUSION SETS
K884102 · Quinton, Inc. · Jan 1989
WINGED INFUSION SET
K885264 · E-Z-Em, Inc. · Jan 1989