FDA product code BTY: Calculator, Predicted Values, Pulmonary Function
BTY is the FDA product code for calculator, predicted values, pulmonary function. It is a Class II device, regulated under 21 CFR 868.1890 and reviewed by the Anesthesiology panel. FDA has cleared 63 510(k) submissions under BTY, 5 in the last five years, from 39 different applicants. The average 510(k) review took 158 days (median 106); 279 days on average over the last three years. FDA has posted 4 recalls for BTY devices.
Classification
| Field | Value |
|---|---|
| Device name | Calculator, Predicted Values, Pulmonary Function |
| Device class | Class II |
| Regulation | 21 CFR 868.1890 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BTY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 264 |
| 2019 | 2 | 342 |
| 2020 | 1 | 315 |
| 2021 | 1 | 129 |
| 2022 | 1 | 99 |
| 2023 | 1 | 268 |
| 2024 | 3 | 279 |
Top BTY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Viasys Healthcare GmbH | 5 | 2008-08-20 |
| Eresearchtechnology GmbH | 3 | 2024-05-28 |
| Cosmed Srl | 3 | 2020-02-06 |
| Carefusion Germany 234 GmbH | 3 | 2012-11-19 |
| Medical Associated Services, Inc. | 3 | 1988-09-29 |
34 more applicants have BTY clearances. See the full list in Caduvo.
Most recent BTY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242809 | Medical Graphics Corporation | Ascent Cardiorespiratory Diagnostic Software | 2024-10-17 | 30 |
| K223629 | Eresearchtechnology GmbH | SpiroSphere, SpiroSphereECG, CardioSphere | 2024-05-28 | 540 |
| K231561 | Guangzhou Homesun Medical Technology Co., Ltd. | Pulmonary Function Tester, Model: A9 | 2024-02-21 | 266 |
| K222982 | Virtus Technology Aps | Virtus Metabolic Monitor | 2023-06-23 | 268 |
| K221030 | Vitalograph Ireland, Ltd. | Model 9100 PFT/DICO | 2022-07-15 | 99 |
Recalls for BTY devices
4 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-08-15.
| Year | Recalls |
|---|---|
| 2017 | 2 |
Frequently asked questions
What is FDA product code BTY?
BTY is the FDA product code for calculator, predicted values, pulmonary function. It is a Class II device, regulated under 21 CFR 868.1890 and reviewed by the Anesthesiology panel.
What device class is BTY?
Class II, regulation 21 CFR 868.1890. Typical premarket route: 510(k).
How long does a 510(k) take for product code BTY?
Across 63 cleared submissions the average was 158 days from receipt to decision (median 106).
Which companies have the most BTY clearances?
Viasys Healthcare GmbH (5); Eresearchtechnology GmbH (3); Cosmed Srl (3); Carefusion Germany 234 GmbH (3); Medical Associated Services, Inc. (3).
Have BTY devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2017-08-15.
Next steps
- Run an FDA pathway report with predicate devices for product code BTY
- Run a recall and safety report across every BTY manufacturer
- Watch product code BTY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.