Cleared Traditional

BT-1 INFUSION PUMP (K881759) - FDA 510(k) Clearance

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

K881759 · Ferring Laboratories, Inc. · General Hospital
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Feb 1989
Decision
309d
Days
Class 2
Risk

K881759 is an FDA 510(k) clearance for the BT-1 INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Ferring Laboratories, Inc. (Suffern, US). The FDA issued a Cleared decision on February 28, 1989 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Ferring Laboratories, Inc. devices

Submission Details

510(k) Number K881759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1988
Decision Date February 28, 1989
Days to Decision 309 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
180d slower than avg
Panel avg: 129d · This submission: 309d
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 235
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K881759.
60 MICROBORE EXTENSION SET W/ANTI-SIPHON VALVE
K892906 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1989
BASAL/BOLUS INFUSORS
K884505 · Baxter Healthcare Corp · Jul 1989
RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP
K890282 · Abbott Laboratories · Apr 1989
LIFECARE MICRO PUMP
K883796 · Abbott Laboratories · Feb 1989
FLO-GARD VP
K884014 · Baxter Healthcare Corp · Dec 1988
BARD INFUSOR PUMP
K883577 · C.R. Bard, Inc. · Nov 1988