# K111013: ACEM

- Pathway: 510(k) (Traditional)
- Applicant: Sandhill Scientific, Inc.
- Decided: Dec 19, 2011 after 252 days
- Product code: FFZ (Cord, Electric, For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K853124 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023238: Mcpulse, Meridian Co., Ltd. (2003) Summary page 2.
- DEN990005: The 3PM Egg Machine, 3pm Co., Inc. (1999). Our reading of the summary gave K984637, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN990005, The 3PM Egg Machine (3pm Co., Inc.), granted Aug 20, 1999; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Indications for use
Plethysmography Module: The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography. Electrogastrography (EGG) Module: A device that receives, records, and produces a visual display of the myoelectrical signal produced by the stomach as an aid to diagnosis of various gastric disorders.

Source page: https://510kreport.com/device/K111013
Methodology: https://510kreport.com/methodology