# K921707: Pentax Naso-Pharyngo-Laryngoscope FNL-15P2/15RP2

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Jul 1, 1992 after 82 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
258 later devices descend from it; 4 cite it directly.
5 of 259 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- 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
- K061313: Evis Exera 180 System (2006), 158 descendants of its own

## Recalls of this device
- Apr 6, 2016 · Class II · Z-2074-2016: Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Source page: https://510kreport.com/device/K921707
Methodology: https://510kreport.com/methodology