# K981543: Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary Equipment

- Pathway: 510(k) (Traditional)
- Applicant: The Olympus Optical Co.
- Decided: Jun 8, 1998 after 39 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931154 (1993). 5 ancestors in all.
431 later devices descend from it; 7 cite it directly.
6 of 437 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850978: Olympus LF-1 Intubation Scope, Olympus Corp. (1985) Summary page 1.
- K963033: BF 240/P240/IT240 Bronchovideoscope & Accessories, Olympus America, Inc. (1996) Summary page 1.
- K931154: Evis 200 System, Olympus Corp. (1993) Summary page 1.
- K923982: Olympus Oes Laparoscopy System, Olympus Corp. (1993) Summary page 1.
- K944072: Olympus Nasal and Sinus Endoscopes, Olympus America, Inc. (1995) Summary page 1.

## Most influential descendants
- K021074: Visera Cystovideoscope Olympus Cyf Type V/VA (2002), 268 descendants of its own
- K013591: Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment (2001), 176 descendants of its own
- K021073: Visera Rhinlaryngovideoscope Olympus Enf Type V (2002), 160 descendants of its own
- K052452: Visera Rhino-Laryngovideoscope Olympus Enf Type VT (2005), 159 descendants of its own
- K031648: Visera Rhino-Laryngovideoscope Olympus Enf Type V (2003), 159 descendants of its own

## Recalls of this device
- Sep 28, 2023 · Class II · Z-0557-2024: Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.
- Sep 25, 2023 · Class II · Z-0332-2024: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the poten
- Sep 25, 2023 · Class II · Z-0338-2024: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the poten
- Sep 25, 2023 · Class II · Z-0344-2024: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the poten
- Jul 27, 2023 · Class II · Z-2504-2023: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

## Indications for use
Olympus LF-TP and LF-DP Tracheal Intubation Fiberscope, accessories and ancillary equipment are intended for airway management which includes endoscopic observation to assess airway anatomy, endotracheal/endobronchial intubation, and management.

Source page: https://510kreport.com/device/K981543
Methodology: https://510kreport.com/methodology