Cleared Traditional

K942161 - LOCKBOX

K942161 is an FDA 510(k) clearance for LOCKBOX, manufactured by Pharmacia Deltec, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K942161 · Pharmacia Deltec, Inc. · General Hospital
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Aug 1994
Decision
90d
Days
Class 2
Risk

K942161 is an FDA 510(k) clearance for the LOCKBOX. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Pharmacia Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on August 2, 1994 after a review of 90 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K942161

510(k) Number K942161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received May 04, 1994
Decision Date August 02, 1994
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 848
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K942161.
SIGMA 8000 AND SIGMA 8002
K942162 · Sigma Intl. · Oct 1994
SIEMENS FLUID DELIVERY SYSTEM, MMT-9500
K933545 · Siemens Infusions Systems · Sep 1994
3M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION)
K940446 · Minnesota Mining and Mfg. Co. · Aug 1994
SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP
K941984 · Sabratek Corp. · Jul 1994
PROVIDER ANNE INFUSER
K922702 · Abbott Laboratories · Jul 1994
STRATOFUSE PCA II INFUSER
K941151 · Infusion Technology Intl. · Jul 1994
K942161 · LOCKBOX
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