Cricothyrotomy Tube
FDA 510(k) K983000 · Polamedco, Inc.
510(k) numberK983000
Submission
- Device name
- Cricothyrotomy Tube
- Applicant
- Polamedco, Inc.
Marina Del Rey, CA, US - Received
- August 27, 1998
- Decision date
- October 27, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTO – Tube, Tracheostomy (W/Wo Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5800
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BTO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253063 | Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series)…BTO · Special | Vitaltec Corporation | 09/11/2026SE |
| K242921 | 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes…BTO · Traditional | Vitaltec Corporation | 06/10/2025SE |
| K233713 | Pilling Tracheostomy TubesBTO · Traditional | Teleflex Medical | 03/22/2024SE |
| K192511 | Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy Tube)…BTO · Traditional | Venner Medical (Singapore) Pte, Ltd. | 07/22/2020SE |
| K173384 | BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated…BTO · Traditional | Smiths Medical Ads, Inc. | 04/10/2018SE |
| K120079 | Primed Tracheostomy Tubes (Multiple)BTO · Traditional | Primed Halberstadt Medizintechnik GmbH | 05/24/2012SE |
| K101721 | Well Lead Tracheostomy Tube and Disposable Inner CannulaBTO · Special | Regulatory and Marketing Services, Inc. | 03/24/2011SE |
| K100950 | Venner Pneux P.Y. (TM) Tracheostomy TubeBTO · Traditional | Venner Medical (Singapore) Pte, Ltd. | 07/13/2010SE |
| K100480 | Rota-Trach Tracheostomy Tube Model Rota-TrachBTO · Traditional | Vitaltec Corporation | 06/11/2010SE |
| K100283 | Versatube Tapered Tracheostomy Tube with Disposable Inner Cannula, Multiple, Prefixes…BTO · Traditional | Cook, Inc. | 04/23/2010SE |
More from Cook, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954383 | Sureloc Circuit ConnectorBZA · Traditional | 12/22/1995SE |
| K953793 | IntroscopeBZT · Traditional | 11/29/1995SE |
| K950713 | Airguide StyletteBSR · Traditional | 05/17/1995SE |
| K933596 | Gastric, Catheter, Irrigation & AspirationBSS · Traditional | 02/13/1995SE |
| K950380 | Flextitip StyletteBSR · Traditional | 02/10/1995SE |
| K920900 | Polamedco Tracheal and Nasotracheal TubesBTR · Traditional | 03/18/1992SE |
| K900456 | Polamedco Nasopaharyngeal AirwayBTQ · Traditional | 04/19/1990SE |
| K900457 | Cuffed Linder Nasotracheal AirwayBTR · Traditional | 04/16/1990SE |
| K894516 | Visoshield(Tm), Surgical Eye ProtectorFXX · Traditional | 09/12/1989SE |
| K881496 | Linder Nasotracheal AirwayBTR · Traditional | 05/31/1988SE |
Questions and answers
When was Cricothyrotomy Tube cleared by the FDA?
Cricothyrotomy Tube (K983000) received a 510(k) decision of Substantially Equivalent on October 27, 1999, 426 days after the submission was received.
What is the product code of K983000?
The FDA product code is BTO – Tube, Tracheostomy (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5800.