Cleared Traditional

K821712 - INFORMED REMOTE FIELD UNIT MODEL IFM1000

K821712 is an FDA 510(k) clearance for INFORMED REMOTE FIELD UNIT MODEL IFM1000, manufactured by Burditt & Calkins-Siemens-Elema. The device is a Class 2 Anesthesiology device with product code BTY cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K821712 · Burditt & Calkins-Siemens-Elema · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1982
Decision
47d
Days
Class 2
Risk

K821712 is an FDA 510(k) clearance for the INFORMED REMOTE FIELD UNIT MODEL IFM1000. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Burditt & Calkins-Siemens-Elema (Mchenry, US). The FDA issued a Cleared decision on July 26, 1982 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1890 - 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 Burditt & Calkins-Siemens-Elema devices

FDA 510(k) Submission Details - K821712

510(k) Number K821712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1982
Decision Date July 26, 1982
Days to Decision 47 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 140d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTY Device Classification - Class 2, Special Controls

Product Code BTY Calculator, Predicted Values, Pulmonary Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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 - BTY Calculator, Predicted Values, Pulmonary Function

All 36
Devices cleared under the same product code (BTY) and FDA review panel - the closest regulatory comparables to K821712.
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K812792 · Medical Graphics Corp. · Nov 1981
ELECTRONIC SPIROMETER MODEL MFR-8100
K810712 · Nihon Kohden America, Inc. · Mar 1981