Cleared Traditional

K970061 - ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)

K970061 is an FDA 510(k) clearance for ACCUTORR PLUS NON INVASIVE BLOOD PRESSU..., manufactured by Datascope Corp.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K970061 · Datascope Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
261d
Days
Class 2
Risk

K970061 is an FDA 510(k) clearance for the ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX). Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on September 25, 1997 after a review of 261 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Datascope Corp. devices

FDA 510(k) Submission Details - K970061

510(k) Number K970061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1997
Decision Date September 25, 1997
Days to Decision 261 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 140d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 547
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K970061.
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL9366
K972786 · Alexander Mfg. Co. · Oct 1997
SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)
K971628 · Somanetics Corp. · Oct 1997
INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF
K971273 · Bio-Tek Instruments, Inc. · Oct 1997
NPB-195 PULSE OXIMETER
K972468 · Nellcor Puritan Bennett, Inc. · Sep 1997
SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
K973222 · Siemens Medical Solutions USA, Inc. · Sep 1997
COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR
K970769 · Aristo Medical · Aug 1997