FDA product code BSR: Stylet, Tracheal Tube
BSR is the FDA product code for stylet, tracheal tube. It is a Class I device, regulated under 21 CFR 868.5790 and reviewed by the Anesthesiology panel. FDA has cleared 32 510(k) submissions under BSR, from 24 different applicants. The average 510(k) review took 134 days (median 85). FDA has posted 16 recalls for BSR devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Stylet, Tracheal Tube |
| Device class | Class I |
| Regulation | 21 CFR 868.5790 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for BSR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 316 |
Compare with all 510(k) review times · Search every BSR clearance
Top BSR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Scientific Sales Intl., Inc. | 3 | 1995-08-25 |
| Augustine Medical, Inc. | 3 | 1992-04-23 |
| Laerdal Medical Corp. | 2 | 1996-09-05 |
| Stebar Instrument Corp. | 2 | 1995-06-12 |
| Polamedco, Inc. | 2 | 1995-05-17 |
19 more applicants have BSR clearances. See the full list in Caduvo.
Most recent BSR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K162729 | Cook Incorporated | Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip | 2017-08-11 | 316 |
| K962361 | Laerdal Medical Corp. | TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND | 1996-09-05 | 78 |
| K954771 | Laerdal Medical Corp. | TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND) | 1996-05-09 | 205 |
| K943104 | Molloy Corp. | MOLLOY INTUBATING STYLETTE | 1996-04-18 | 659 |
| K955238 | Rusch Intl. | RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE | 1996-02-06 | 84 |
Recalls for BSR devices
16 product recalls in 10 recall events; 3 initiated in the last five years and 4 still open. Most recent: 2024-10-28.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2024 | 3 |
Frequently asked questions
What is FDA product code BSR?
BSR is the FDA product code for stylet, tracheal tube. It is a Class I device, regulated under 21 CFR 868.5790 and reviewed by the Anesthesiology panel.
What device class is BSR?
Class I, regulation 21 CFR 868.5790. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BSR?
Across 32 cleared submissions the average was 134 days from receipt to decision (median 85).
Which companies have the most BSR clearances?
Scientific Sales Intl., Inc. (3); Augustine Medical, Inc. (3); Laerdal Medical Corp. (2); Stebar Instrument Corp. (2); Polamedco, Inc. (2).
Have BSR devices been recalled?
Yes: 16 product recalls across 10 recall events; the most recent began 2024-10-28.
Next steps
- Run an FDA pathway report with predicate devices for product code BSR
- Run a recall and safety report across every BSR manufacturer
- Watch product code BSR 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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