Cleared Traditional

K932740 - HOMEPUMP NSF

K932740 is an FDA 510(k) clearance for HOMEPUMP NSF, manufactured by Block Medical, Inc.. The device is a Class 2 General Hospital device with product code MED cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K932740 · Block Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
120d
Days
Class 2
Risk

K932740 is an FDA 510(k) clearance for the HOMEPUMP NSF. Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Block Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 6, 1993 after a review of 120 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6885 - 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 Block Medical, Inc. devices

FDA 510(k) Submission Details - K932740

510(k) Number K932740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1993
Decision Date October 06, 1993
Days to Decision 120 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
9d faster than avg
Panel avg: 129d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MED Device Classification - Class 2, Special Controls

Product Code MED Sterilant, Medical Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6885
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 - MED Sterilant, Medical Devices

All 53
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K932740.
PERACT 20 LIQUID STERILANT
K960513 · Minntech Corp. · Oct 1997
WAVICIDE MONITOR STRIPS
K932047 · Serim Research Corp. · Jun 1994
CIDEX FORMULA 7* LONG-LIFE ACTIVATED DIALDEHYDE
K924334 · Johnson & Johnson Medical, Inc. · Mar 1994
PYMAH COLD STERILOG GLUTARALDEHYDE MONITOR
K915170 · Pymah Corp. · Jul 1992
SERIM DISINTEK REAGENT STRIPS
K913943 · Serim Research Corp. · Mar 1992