# K984528: Parker Flex-Tip Tracheal Tube

- Pathway: 510(k) (Traditional)
- Applicant: Parker Medical Assoc.
- Decided: Jul 15, 1999 after 206 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K822082 (1982). 1 ancestor in all.
18 later devices descend from it; 2 cite it directly.
2 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K822082: Sheridan/HVT,CF, Uncuffed, Sheridan Catheter Corp. (1982) Summary page 1.

## Most influential descendants
- K052233: Tracheoscopic Ventilation Tube (TVT) System (2005), 16 descendants of its own
- K082420: Tracheoscopic Ventilation Tube (TVT) (2008), 14 descendants of its own
- K113576: Double Lumen Video Tracheosdope (DLVT) System (2012), 4 descendants of its own
- K123853: Vivasight-DL System (2013), 3 descendants of its own
- K121028: Etview Tracheoscopic Ventilation Tube (TVT (TM)) (2012), 3 descendants of its own

## Recalls of this device
- Dec 16, 2016 · Class II · Z-1399-2017: The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended.

## Indications for use
Parker cuffed tubes are designed for oral intubation and are indicated for airway management.

Source page: https://510kreport.com/device/K984528
Methodology: https://510kreport.com/methodology