Cleared Traditional

PRI. PIGGYBACK I.V. W/DUAL PIERCING PIN (K800137) - FDA 510(k) Clearance

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

K800137 · Abbott Laboratories · General Hospital
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Mar 1980
Decision
59d
Days
Class 2
Risk

K800137 is an FDA 510(k) clearance for the PRI. PIGGYBACK I.V. W/DUAL PIERCING PIN. 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 March 20, 1980 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Laboratories devices

Submission Details

510(k) Number K800137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1980
Decision Date March 20, 1980
Days to Decision 59 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
70d faster than avg
Panel avg: 129d · This submission: 59d
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 K800137.
VOLUMETRIC PUMP CASSETTE W/ATTACHED SET
K800711 · Travenol Laboratories, S.A. · May 1980
B-D STASET, I.V. FLOW CONTROLLER
K800600 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1980
LOW PLASTICIZER ADMINISTRATION SETS
K791496 · Travenol Laboratories, S.A. · Apr 1980
VENTED I.V. SET
K792228 · Abbott Laboratories · Jan 1980
CONTINU-FLO ADMIN. SET CODE 2C/200
K792538 · Travenol Laboratories, S.A. · Dec 1979
IV EXTENSION SET SL
K791930 · Abbott Laboratories · Oct 1979