Trachlight Stylet & Tracheal Lightwand (Original Application Name: Stylett & Tracheal Lightwand)
FDA 510(k) K954771 · Laerdal Medical Corp.
510(k) numberK954771
Submission
- Device name
- Trachlight Stylet & Tracheal Lightwand (Original Application Name: Stylett & Tracheal Lightwand)
- Applicant
- Laerdal Medical Corp.
Wappingers Falls, NY, US - Received
- October 17, 1995
- Decision date
- May 9, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BSR – Stylet, Tracheal Tube
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5790
- Specialty
- Anesthesiology
Other 510(k)s with product code BSR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162729 | Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange…BSR · Traditional | Cook Incorporated | 08/11/2017SE |
| K962361 | Trachlight Stylet and Tracheal LightwandBSR · Traditional | Laerdal Medical Corp. | 09/05/1996SE |
| K943104 | Molloy Intubating StyletteBSR · Traditional | Molloy Corp. | 04/18/1996SE |
| K955238 | Rusch Schroeder Endotracheal Tube StyleBSR · Traditional | Rusch Intl. | 02/06/1996SE |
| K953677 | Lighted Flexguide (Modification)BSR · Traditional | Scientific Sales Intl., Inc. | 08/25/1995SE |
| K952100 | Rusch Endotracheal Tube StyletBSR · Traditional | Rusch, Inc. | 08/08/1995SE |
| K952266 | Schroeder Oral/Nasal Directional StyletteBSR · Traditional | Stebar Instrument Corp. | 06/12/1995SE |
| K950713 | Airguide StyletteBSR · Traditional | Polamedco, Inc. | 05/17/1995SE |
| K950380 | Flextitip StyletteBSR · Traditional | Polamedco, Inc. | 02/10/1995SE |
| K944729 | Stylet Sheath with Locking Cap and Reusable Battery Operated Light SourceBSR · Traditional | Coast Medical, Inc. | 12/21/1994SE |
More from Coast Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251631 | The BAG manual resuscitator and accessoriesBTM · Traditional | 11/24/2025SE |
| K232111 | NeoBeat, NeoBeat MiniMWI · Traditional | 06/25/2024SE |
| K183348 | Reusable Silicone Cover CPRmeter 2LIX · Special | 12/17/2018SE |
| K173886 | CPRmeter 2 CPR Feedback DeviceLIX · Traditional | 03/23/2018SE |
| K151702 | Reusable Full Silicone CoverLIX · Special | 08/13/2015SE |
| K001742 | Resusci Inflate-A-Shield CPR BarrierCBP · Traditional | 10/06/2000SE |
| K962361 | Trachlight Stylet and Tracheal LightwandBSR · Traditional | 09/05/1996SE |
| K954609 | Heartstart 911MKJ · Traditional | 01/04/1996SE |
| K950698 | Lsu 2000 Portable Suction UnitJCX · Traditional | 05/09/1995SE |
| K933048 | Laerdal(Tm) Pocket Mask, ModificationKGB · Traditional | 12/02/1993SE |
Questions and answers
When was Trachlight Stylet & Tracheal Lightwand (Original Application Name: Stylett & Tracheal Lightwand) cleared by the FDA?
Trachlight Stylet & Tracheal Lightwand (Original Application Name: Stylett & Tracheal Lightwand) (K954771) received a 510(k) decision of Substantially Equivalent on May 9, 1996, 205 days after the submission was received.
What is the product code of K954771?
The FDA product code is BSR – Stylet, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5790.