Cleared Special

K070858 - EXPRESS SERIES

K070858 is an FDA 510(k) clearance for EXPRESS SERIES, manufactured by Medical Graphics Corp.. The device is a Class 2 Anesthesiology device with product code BZL cleared through the Special 510(k) pathway after a 19-day FDA review.

K070858 · Medical Graphics Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
19d
Days
Class 2
Risk

K070858 is an FDA 510(k) clearance for the EXPRESS SERIES. Classified as Computer, Oxygen-uptake (product code BZL), Class II - Special Controls.

Submitted by Medical Graphics Corp. (St. Paul, US). The FDA issued a Cleared decision on April 16, 2007 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1730 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medical Graphics Corp. devices

FDA 510(k) Submission Details - K070858

510(k) Number K070858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2007
Decision Date April 16, 2007
Days to Decision 19 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 140d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

BZL Device Classification - Class 2, Special Controls

Product Code BZL Computer, Oxygen-uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1730
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BZL Computer, Oxygen-uptake

All 11
Devices cleared under the same product code (BZL) and FDA review panel - the closest regulatory comparables to K070858.
Breezing Med
K200076 · Tf Health Co. · Sep 2020
NICU V'02
K190561 · Cosmed Nordic Aps · Sep 2020
MEDGRAPHICS ULTIMA SYSTEM
K061731 · Medical Graphics Corp. · Sep 2006
7250 METABOLIC MONITOR
K924978 · Puritan Bennett Corp. · Sep 1994
DELTATRAC(TM) II METABOLIC MONITOR
K931422 · Datex Division Instrumentarium Corp. · Nov 1993
DELTATRAC(TM) METABOLIC MONITOR
K864603 · Datex Division Instrumentarium Corp. · Mar 1987