Cleared Traditional

K925112 - BIO CLINIC UNDER PATIENT SCALE

K925112 is an FDA 510(k) clearance for BIO CLINIC UNDER PATIENT SCALE, manufactured by Sunrise Medical, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K925112 · Sunrise Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
252d
Days
Class 2
Risk

K925112 is an FDA 510(k) clearance for the BIO CLINIC UNDER PATIENT SCALE. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Sunrise Medical, Inc. (Ontario, US). The FDA issued a Cleared decision on June 18, 1993 after a review of 252 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 Sunrise Medical, Inc. devices

FDA 510(k) Submission Details - K925112

510(k) Number K925112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1992
Decision Date June 18, 1993
Days to Decision 252 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 129d · This submission: 252d
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 476
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K925112.
INFUSION PUMP
K930781 · Y · Aug 1993
IVAC SYRING PUMP MODEL 770
K925091 · Y · Jul 1993
MODEL 880 INFUSION PUMP, MODIFICATION
K924871 · 3M Health Care, Ltd. · Jun 1993
BARD EPIDURAL PUMP
K925196 · C.R. Bard, Inc. · Jun 1993
MODEL 285 INFUSION PUMP, MODIFICATION
K924865 · 3M Health Care, Ltd. · Jun 1993
MODEL 285CM INFUSION PUMP, MODIFICATION
K924866 · 3M Health Care, Ltd. · Jun 1993