FDA product code JCT: Prosthesis, Tracheal, Expandable
JCT is the FDA product code for prosthesis, tracheal, expandable. It is a Class II device, regulated under 21 CFR 878.3720 and reviewed by the Anesthesiology panel. FDA has cleared 45 510(k) submissions under JCT, 2 in the last five years, from 16 different applicants. The average 510(k) review took 135 days (median 99). FDA has posted 61 recalls for JCT devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Tracheal, Expandable |
| Device class | Class II |
| Regulation | 21 CFR 878.3720 |
| Review panel | AN — Anesthesiology |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for JCT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 137 |
| 2020 | 1 | 225 |
| 2021 | 2 | 240 |
| 2022 | 1 | 144 |
| 2023 | 1 | 164 |
Compare with all 510(k) review times · Search every JCT clearance
Top JCT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Scientific Scimed, Inc. | 9 | 2002-07-09 |
| Alveolus, Inc. | 8 | 2009-03-11 |
| Boston Scientific Corp | 4 | 2012-08-03 |
| Boston Scientific Corporation | 3 | 2023-07-14 |
| Micro-Tech (Nanjing) Co., Ltd. | 3 | 2022-07-08 |
11 more applicants have JCT clearances. See the full list in Caduvo.
Most recent JCT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230269 | Boston Scientific Corporation | Ultraflex Tracheobronchial Stent System | 2023-07-14 | 164 |
| K220424 | Micro-Tech (Nanjing) Co., Ltd. | Through the Scope Tracheal Stent System | 2022-07-08 | 144 |
| K212403 | Micro-Tech (Nanjing) Co., Ltd. | Tracheal Stent System (Y-Shaped) | 2021-10-30 | 89 |
| K202204 | Micro-Tech (Nanjing) Co., Ltd. | Tracheal Stent System | 2021-09-01 | 392 |
| K201342 | M.I.Tech Co., Ltd. | HANAROSTENT Trachea/Bronchium (CCC) | 2020-12-31 | 225 |
Recalls for JCT devices
61 product recalls in 9 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2022-03-03.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 5 |
| 2022 | 2 |
Frequently asked questions
What is FDA product code JCT?
JCT is the FDA product code for prosthesis, tracheal, expandable. It is a Class II device, regulated under 21 CFR 878.3720 and reviewed by the Anesthesiology panel.
What device class is JCT?
Class II, regulation 21 CFR 878.3720. Typical premarket route: 510(k).
How long does a 510(k) take for product code JCT?
Across 45 cleared submissions the average was 135 days from receipt to decision (median 99).
Which companies have the most JCT clearances?
Boston Scientific Scimed, Inc. (9); Alveolus, Inc. (8); Boston Scientific Corp (4); Boston Scientific Corporation (3); Micro-Tech (Nanjing) Co., Ltd. (3).
Have JCT devices been recalled?
Yes: 61 product recalls across 9 recall events; the most recent began 2022-03-03.
Next steps
- Run an FDA pathway report with predicate devices for product code JCT
- Run a recall and safety report across every JCT manufacturer
- Watch product code JCT 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.
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