# K080722: Primado Surgical Drill

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Sep 17, 2008 after 188 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K083112: Primado (2009), 7 descendants of its own
- K132264: PRIMADO2 Total Surgical System (2013), 6 descendants of its own
- K233638: VERZA™ High Speed Drills (2024), 1 descendant of its own
- K213221: AMADEO, M-UK1015 (incl. attachments and accessories) (2022), 1 descendant of its own
- K202120: P300 Attachment (2021), 1 descendant of its own

## Indications for use
The Primado is an electrically powered surgical system for delicate bone dissection in the ear, nose and throat areas. A wide range of attachments includes a perforator drive, craniotome, straight/angle/malleable drills, and microsaws.

Source page: https://510kreport.com/device/K080722
Methodology: https://510kreport.com/methodology