Cleared Traditional

K884891 - OC-100 OXIMETER INTERFACE CALIBRATOR

K884891 is an FDA 510(k) clearance for OC-100 OXIMETER INTERFACE CALIBRATOR, manufactured by Telediagnostic Systems, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K884891 · Telediagnostic Systems, Inc. · Anesthesiology device
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Dec 1988
Decision
36d
Days
Class 2
Risk

K884891 is an FDA 510(k) clearance for the OC-100 OXIMETER INTERFACE CALIBRATOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Telediagnostic Systems, Inc. (San Francisco, US). The FDA issued a Cleared decision on December 28, 1988 after a review of 36 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. 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 Telediagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K884891

510(k) Number K884891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1988
Decision Date December 28, 1988
Days to Decision 36 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 140d · This submission: 36d
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 524
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K884891.
AL-800PA PULSE OXIMETER MODULE
K884536 · Nihon Kohden America, Inc. · Feb 1989
MODEL 8700 PULSE OXIMETER
K890033 · Nonin Medical, Inc. · Feb 1989
EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS.
K884614 · Edentec Corp. · Feb 1989
SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER
K884329 · Baxter Healthcare Corp · Dec 1988
OLV 1100
K881307 · Nihon Kohden America, Inc. · Nov 1988
BM-103 BATTERY MODULE
K883877 · Datex Division Instrumentarium Corp. · Oct 1988