Cleared Traditional

K884505 - BASAL/BOLUS INFUSORS

K884505 is an FDA 510(k) clearance for BASAL/BOLUS INFUSORS, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K884505 · Baxter Healthcare Corp · General Hospital
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Jul 1989
Decision
262d
Days
Class 2
Risk

K884505 is an FDA 510(k) clearance for the BASAL/BOLUS INFUSORS. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on July 14, 1989 after a review of 262 days - an extended review 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: 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K884505

510(k) Number K884505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1988
Decision Date July 14, 1989
Days to Decision 262 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
133d slower than avg
Panel avg: 129d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

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 601
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K884505.
LIFECARE MICRO PUMP
K883645 · Abbott Laboratories · Aug 1989
IVSK09 CALIBRATION KIT AN ACCESSORY TO IV7000/7200
K890786 · Valleylab, Inc. · Jul 1989
60 MICROBORE EXTENSION SET W/ANTI-SIPHON VALVE
K892906 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1989
IVAC VARIABLE PRESSURE VOLUMETRIC PUMP, 570 SERIES
K891583 · Y · Jun 1989
RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP
K890282 · Abbott Laboratories · Apr 1989
CADD-PCA MODEL 5800 AMBULATORY INFUSION PUMP
K890062 · Pharmacia Deltec, Inc. · Mar 1989