Cleared Traditional

K881759 - BT-1 INFUSION PUMP

K881759 is an FDA 510(k) clearance for BT-1 INFUSION PUMP, manufactured by Ferring Laboratories, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 309-day FDA review.

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

FDA 510(k) Submission Details - K881759

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.

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 618
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K881759.
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
MODIFIED MINIMED MDL404-SP/504-S DRUG INSULIN PUMP
K890457 · Medtronic Minimed · Mar 1989
LIFECARE MICRO PUMP
K883796 · Abbott Laboratories · Feb 1989
MODIFIED IMED GEMINI PC-1 INFUSION PUMP
K883993 · Imed Corp. · Dec 1988
FLO-GARD VP
K884014 · Baxter Healthcare Corp · Dec 1988