# K120151: Nebulae I

- Pathway: 510(k) (Traditional)
- Applicant: Northgate Technologies, Inc.
- Decided: Aug 17, 2012 after 212 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K964171 (1997). 16 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063367: 45L Core Insufflator, Model F114, W.O.M. World of Medicine AG (2007) Summary page 2.
- K022052: 40LPM Abdominal Insufflator, Catalog # 72-00203-0, Northgate Technologies, Inc. (2003) Summary page 2.

## Most influential descendants
- K153513: Insufflator 50L FM134 (2016), 21 descendants of its own
- K170784: Pneumoclear (2017), 17 descendants of its own
- K201361: Pneumoclear (2020), 14 descendants of its own
- K232610: da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation (2024), 11 descendants of its own
- K251739: da Vinci Surgical System (IS5000) (2026), 2 descendants of its own

## Recalls of this device
- Jan 15, 2021 · Class II · Z-1147-2021: An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
- Nov 21, 2016 · Class II · Z-0866-2017: Device could cause a patient overpressure situation without any visual or auditory indication or warning

## Indications for use
The Nebulae TM 1 50 LPM Insufflator provides CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic Pediatric Laparoscopic Bariatric Laparoscopic Minimally Invasive Vessel Harvesting

Source page: https://510kreport.com/device/K120151
Methodology: https://510kreport.com/methodology