510(k) · Cleared
ClearedACEM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sandhill Scientific, Inc. · FFZ Cord, Electric, For Endoscope
Cleared on Dec 19, 2011 as substantially equivalent to K023238 (Meridian Co., Ltd., 2003) and 1 other predicate after a 252-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Dec 19, 2011
- Review
- 252 days
- Class
- Class II
- Product code
- FFZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K853124 (1985). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K853124 | Novametrix Pulse Oximeter, Model 500 | Novametrix Medical Systems, Inc. | 1985 | — |
| −1 | K023238 | Mcpulse | Meridian Co., Ltd. | 2003 | — |
| 0 (this device) | K111013 | ACEM | Sandhill Scientific, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FFZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023238 | McpulseSummary page 2…Page I of 2 Substantial Equivalence The plethysmograph module is substantially equivalent to the Meridian McPulse device K023238. The EGO module is substantially equivalent to the 3CPM EGG machine K984637.… | 2003 |
| * | DEN990005 | The 3PM Egg Machine 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. | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 17.3 years on median.
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K023238.
How does its category compare?
All FFZ devicesFFZ Cord, Electric, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FFZ
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · FFZ
Too few FFZ 510(k)s in any year since 2007 to give a median.
Recalls per year · FFZ
No recall names FFZ since 2007.
Adverse event reports per year · FFZ
1in 2016
MAUDE reports naming product code FFZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 7 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111013 · printed Nov 5, 2026
Cite this page
510(k) Report. “K111013: ACEM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111013
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026