Cleared Traditional

K872517 - TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM

K872517 is an FDA 510(k) clearance for TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM, manufactured by D. E. Hokanson, Inc.. The device is a Class 2 Cardiovascular device with product code JOM cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K872517 · D. E. Hokanson, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
99d
Days
Class 2
Risk

K872517 is an FDA 510(k) clearance for the TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM. Classified as Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (product code JOM), Class II - Special Controls.

Submitted by D. E. Hokanson, Inc. (Issaquah, US). The FDA issued a Cleared decision on October 1, 1987 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2780 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all D. E. Hokanson, Inc. devices

FDA 510(k) Submission Details - K872517

510(k) Number K872517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1987
Decision Date October 01, 1987
Days to Decision 99 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 125d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOM Device Classification - Class 2, Special Controls

Product Code JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2780
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

All 32
Devices cleared under the same product code (JOM) and FDA review panel - the closest regulatory comparables to K872517.
VASOCOR PVR 100
K973659 · Vasocor, Inc. · Dec 1997
DOPCORD PPG
K884451 · Huntleigh Technology, Inc. · Jan 1989
3D VASCULAR RECORDER
K883908 · D. E. Hokanson, Inc. · Oct 1988
PULSE CUFF RECORDER MODEL PCR100
K863702 · Imex Medical Systems, Inc. · Jun 1987
VASOPULSE(TM)/MODEL 5000
K863803 · Sonicaid, Inc. · May 1987
OSM-1 OXYGEN SATURATION MONITOR
K853331 · Criticare Systems, Inc. · Jan 1986