Cleared Traditional

K831259 - RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE

K831259 is the FDA 510(k) clearance for RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE by Cardiac Pacemakers, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K831259 · Cardiac Pacemakers, Inc. · General Hospital
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May 1983
Decision
21d
Days
Class 2
Risk

K831259 is an FDA 510(k) clearance for the RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Cardiac Pacemakers, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1983 after a review of 21 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K831259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1983
Decision Date May 09, 1983
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 393
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K831259.
PROMINJET PUMP
K832120 · Abbott Laboratories · Aug 1983
FLO-GARD 6100 VOLUMETRIC INFUSION PUMP
K831258 · Travenol Laboratories, S.A. · Jun 1983
Y-TYPE BACKCHECK MICROBORE EXTEN. SET
K831203 · Abbott Laboratories · Jun 1983
PCA PUMP
K830452 · Abbott Laboratories · Apr 1983
INFUSION PUMP #AS*6H
K830486 · Baxter Healthcare Corp · Apr 1983
GRASE BY DYNAMICS MS 27 SYRINGE DRIVER
K830809 · Intermedics, Inc. · Apr 1983