FDA product code · Anesthesiology · Class 2
BTY: Calculator, Predicted Values, Pulmonary Function
BTY is FDA's product code for "Calculator, Predicted Values, Pulmonary Function": a Class 2 device classified under 21 CFR 868.1890, reviewed by the Anesthesiology panel.
510(k) review time for BTY
Across 10 510(k) clearances under BTY decided from 2018-01-01 to 2026-10-06, the median was 267 days from FDA receipt to decision. Half took between 148 and 304 days, and 80% were decided within 335 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 148 |
| Median | 267 |
| 75th percentile | 304 |
| 80th percentile | 335 |
| 90th percentile | 428 |
| Slowest | 540 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
BTY in the public FDA record
| 510(k) clearances, all years | 64 |
|---|
Counts of records, not of devices or events. Adverse event reports for BTY are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite BTY
2 FDA recognized consensus standards cite BTY, 1 of them recognized only in part, among them ISO 23747 Second edition 2015-08; ISO 26782 First edition 2009-07. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 1-178 ISO 23747 Second edition 2015-08 — Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
- 1-179 ISO 26782 First edition 2009-07 (partial recognition) — Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans [Including: Technical Corrigendum 1 (2009)]
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.