Cleared Special

K001308 - MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW

K001308 is an FDA 510(k) clearance for MODIFICATION TO ZYMED TELEMETRY SYSTEM, manufactured by Agilent Technologies. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 22-day FDA review.

K001308 · Agilent Technologies · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
22d
Days
Class 2
Risk

K001308 is an FDA 510(k) clearance for the MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Agilent Technologies (Oxnard, US). The FDA issued a Cleared decision on May 17, 2000 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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 Agilent Technologies devices

FDA 510(k) Submission Details - K001308

510(k) Number K001308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2000
Decision Date May 17, 2000
Days to Decision 22 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 140d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - DQA Oximeter

All 511
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K001308.
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT
K002574 · Masimo Corp. · Sep 2000
MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500
K001930 · Nonin Medical, Inc. · Jul 2000
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
K001688 · Datex-Ohmeda, Inc. · Jun 2000
MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500
K001085 · Nonin Medical, Inc. · May 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA
K000126 · Masimo Corp. · Apr 2000
MODIFICATION TO MARSPO2, MODEL 2001
K000794 · Novametrix Medical Systems, Inc. · Apr 2000