Cleared Traditional

K792101 - COUITER/CMS ISOTONIC BLOOD BANK SALINE

K792101 is an FDA 510(k) clearance for COUITER/CMS ISOTONIC BLOOD BANK SALINE, manufactured by Coulter Electronics, Inc.. The device is a Class 1 Hematology device with product code JCE cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K792101 · Coulter Electronics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1979
Decision
32d
Days
Class 1
Risk

K792101 is an FDA 510(k) clearance for the COUITER/CMS ISOTONIC BLOOD BANK SALINE. Classified as Solution, Isotonic (product code JCE), Class I - General Controls.

Submitted by Coulter Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 20, 1979 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.4010 - the FDA hematology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Coulter Electronics, Inc. devices

FDA 510(k) Submission Details - K792101

510(k) Number K792101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1979
Decision Date November 20, 1979
Days to Decision 32 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 113d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

JCE Device Classification - Class 1, General Controls

Product Code JCE Solution, Isotonic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.4010
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JCE Solution, Isotonic

Devices cleared under the same product code (JCE) and FDA review panel - the closest regulatory comparables to K792101.
BUFFERED SALINE
K842722 · E K Ind., Inc. · Sep 1984
IMMUNOHEMATOLOGICAL SALINE #97139
K831200 · Emd Chemicals, Inc. · May 1983
CERTIFIED BLOOD BANK SALINE
K801506 · Nobel Scientific Industries, Inc. · Jul 1980
BARBITAL SALINE BUFFER
K761170 · Bio/Data Corp. · Jan 1977
PHYSIOLOGIC SALINE (0.85%)
K761174 · Bio/Data Corp. · Jan 1977