FDA product code BSY: Catheters, Suction, Tracheobronchial
BSY is the FDA product code for catheters, suction, tracheobronchial. It is a Class I device, regulated under 21 CFR 868.6810 and reviewed by the Anesthesiology panel. FDA has cleared 116 510(k) submissions under BSY, from 79 different applicants. The average 510(k) review took 79 days (median 62). FDA has posted 89 recalls for BSY devices, 20 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheters, Suction, Tracheobronchial |
| Device class | Class I |
| Regulation | 21 CFR 868.6810 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BSY clearance
Top BSY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sherwood Medical Co. | 7 | 1996-03-28 |
| Ballard Medical Products | 5 | 1997-02-11 |
| American Pharmaseal Div. Ahsc | 4 | 1987-08-11 |
| Ackrad Laboratories | 4 | 1986-01-10 |
| Puritas Health Care, Inc. | 3 | 1994-05-10 |
74 more applicants have BSY clearances. See the full list in Caduvo.
Most recent BSY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K031997 | Mallinckrodt Dar S.R.L. | MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM | 2003-11-25 | 151 |
| K992902 | Ambu, Inc. | AMBU HAND POWER SUCTION PUMP | 1999-10-25 | 56 |
| K982945 | Spirit Medical Systems, Inc. | DUAL PURPOSE CLOSED CATHETER | 1998-09-22 | 32 |
| K981910 | Ni-Med, Inc. | SUCTION CATHETER | 1998-08-24 | 84 |
| K972258 | Mallinckrodt Medical | HI-CARE CLOSED SUCTION SYSTEM | 1997-12-29 | 195 |
Recalls for BSY devices
89 product recalls in 23 recall events; 20 initiated in the last five years and 18 still open. Most recent: 2025-03-19.
| Year | Recalls |
|---|---|
| 2017 | 11 |
| 2018 | 4 |
| 2019 | 2 |
| 2020 | 3 |
| 2021 | 3 |
| 2022 | 3 |
| 2023 | 5 |
| 2024 | 1 |
| 2025 | 8 |
Frequently asked questions
What is FDA product code BSY?
BSY is the FDA product code for catheters, suction, tracheobronchial. It is a Class I device, regulated under 21 CFR 868.6810 and reviewed by the Anesthesiology panel.
What device class is BSY?
Class I, regulation 21 CFR 868.6810. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BSY?
Across 116 cleared submissions the average was 79 days from receipt to decision (median 62).
Which companies have the most BSY clearances?
Sherwood Medical Co. (7); Ballard Medical Products (5); American Pharmaseal Div. Ahsc (4); Ackrad Laboratories (4); Puritas Health Care, Inc. (3).
Have BSY devices been recalled?
Yes: 89 product recalls across 23 recall events; the most recent began 2025-03-19.
Next steps
- Run an FDA pathway report with predicate devices for product code BSY
- Run a recall and safety report across every BSY manufacturer
- Watch product code BSY 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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