Submission Details
| 510(k) Number | K893866 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 26, 1989 |
| Decision Date | August 07, 1989 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
Cleared
Traditional
K893866 - HOOD PEDIATRIC TRACHEOSTOMY TUBE
(FDA 510(k) Clearance)
Aug 1989
Decision
73d
Days
Class 2
Risk
K893866 is an FDA 510(k) clearance for the HOOD PEDIATRIC TRACHEOSTOMY TUBE. This device is classified as a Tube, Tracheostomy (w/wo Connector) (Class II — Special Controls, product code BTO).
Submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on August 7, 1989, 73 days after receiving the submission on May 26, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
Device Classification
| Product Code | BTO — Tube, Tracheostomy (w/wo Connector) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5800 |
Similar Devices — BTO Tube, Tracheostomy (w/wo Connector)
All 127
K242921 · Vitaltec Corporation
· Jun 2025
K233713 · Teleflex Medical
· Mar 2024
K192511 · Venner Medical (Singapore) Pte, Ltd.
· Jul 2020
K173384 · Smiths Medical Ads, Inc.
· Apr 2018
K120079 · Primed Halberstadt Medizintechnik GmbH
· May 2012
K101721 · Regulatory and Marketing Services, Inc.
· Mar 2011