Pristine Specimen Tube and Introducer System
FDA 510(k) K881514 · Hall Laboratories, Inc.
510(k) numberK881514
Submission
- Device name
- Pristine Specimen Tube and Introducer System
- Applicant
- Hall Laboratories, Inc.
Shawnee, KS, US - Received
- April 11, 1988
- Decision date
- June 16, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BSK – Cuff, Tracheal Tube, Inflatable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5750
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K221477 | AG100sBSK · Traditional | Hospitech Respiration , Ltd. | 12/29/2022SE |
| K202874 | Puritan Bennett Cuff Pressure ManagerBSK · Traditional | Covidien, LLC | 01/09/2021SE |
| K192611 | CuffixBSK · Traditional | Biovo Technologies , Ltd. | 08/13/2020SE |
| K191858 | Pylant MonitorBSK · Traditional | Kal-Med, LLC | 02/24/2020SE |
| K182548 | Accucuff Cuff Pressure IndicatorBSK · Traditional | Tianjin Medis Medical Device Co., Ltd. | 01/25/2019SE |
| K180991 | AG 100sBSK · Traditional | Hospitech Respiration , Ltd. | 10/12/2018SE |
More from Hospitech Respiration , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K874645 | Closed Wound Drainage SystemsGCY · Traditional | 12/02/1987SE |
Questions and answers
When was Pristine Specimen Tube and Introducer System cleared by the FDA?
Pristine Specimen Tube and Introducer System (K881514) received a 510(k) decision of Substantially Equivalent on June 16, 1988, 66 days after the submission was received.
What is the product code of K881514?
The FDA product code is BSK – Cuff, Tracheal Tube, Inflatable, a Class II (moderate risk) device regulated under 21 CFR 868.5750.