Cleared Traditional

K891146 - TERUMO SURFLO INJECTION PLUG

K891146 is an FDA 510(k) clearance for TERUMO SURFLO INJECTION PLUG, manufactured by Terumo Medical Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K891146 · Terumo Medical Corp. · General Hospital
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Jun 1989
Decision
112d
Days
Class 2
Risk

K891146 is an FDA 510(k) clearance for the TERUMO SURFLO(R) INJECTION PLUG. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on June 23, 1989 after a review of 112 days - within the typical 510(k) review window.

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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K891146

510(k) Number K891146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1989
Decision Date June 23, 1989
Days to Decision 112 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
17d faster than avg
Panel avg: 129d · This submission: 112d
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 533
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K891146.
KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES
K892438 · The Kendal Co. · Jul 1989
KENDALL CURITY EXTENSION TUBES
K892440 · The Kendal Co. · Jul 1989
SURFLO(R) WINGED INFUSION SET
K891063 · 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
MONOPLACE HYPERBARIC EXTENSION SET (L 11055)
K884141 · Abbott Laboratories · Feb 1989