510(k) · Cleared
ClearedAccess Alert Gauge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medisystems Corp. · KOC Accessories, Blood Circuit, Hemodialysis
Cleared on Oct 25, 2000 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Oct 25, 2000
- Review
- 82 days
- Class
- Class II
- Product code
- KOC
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK002372 Access Alert GaugeMedisystems Corp. · 2000
- Descendant · cites it directly · 5 of its ownK030456 Vasc-AlertVasc-Alert, LLC · 2003
- Descendant · 2 generations on · 4 of its ownK042566 Vasc-AlertVasc-Alert, Inc. · 2004
- Descendant · 3 generations on · 3 of its ownK093834 Crit-Line Anemia Management SoftwareHema Metrics, LLC · 2010
- Descendant · 4 generations on · 2 of its ownK130579 Physoft AmsPhysicians Software Systems, LLC · 2013
- Descendant · 5 generations on · 0 of its ownK232283 PhySoftAMS®Physician Software Systems, LLC · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K030456Vasc-AlertVasc-Alert, LLC · 2003 · cites it directly5descendants
- K042566Vasc-AlertVasc-Alert, Inc. · 2004 · 2 generations on4descendants
- K093834Crit-Line Anemia Management SoftwareHema Metrics, LLC · 2010 · 3 generations on3descendants
- K130579Physoft AmsPhysicians Software Systems, LLC · 2013 · 4 generations on2descendants
- K232283PhySoftAMS®Physician Software Systems, LLC · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002372 | Access Alert Gauge | Medisystems Corp. | 2000 | — |
| +1 | K030456 | Vasc-Alert | Vasc-Alert, LLC | 2003 | — |
| +2 | K042566 | Vasc-Alert | Vasc-Alert, Inc. | 2004 | — |
| +3 | K093834 | Crit-Line Anemia Management Software | Hema Metrics, LLC | 2010 | — |
| +4 | K130579 | Physoft Ams | Physicians Software Systems, LLC | 2013 | — |
| +5 | K232283 | PhySoftAMS® | Physician Software Systems, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KOC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KOC device
- #1 K230514 Blood Tubing Lines for Hemodialysis AL Series…score 11.8 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030456 | Vasc-Alert | 2003 | 5 |
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?
- Of its descendants, K030456 (Vasc-Alert, LLC, 2003) has gone furthest, with 5 descendants of its own.
How does its category compare?
All KOC devicesKOC Accessories, Blood Circuit, Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KOC
Too few KOC 510(k)s in any year since 2007 to give a median.
Recalls per year · KOC
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KOC
50in 2025
MAUDE reports naming product code KOC, 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 | 1 | — | 0 | 3 |
| 2008 | 2 | — | 2 | 12 |
| 2009 | 2 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 1 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 22 |
| 2014 | 1 | — | 1 | 165 |
| 2015 | 2 | — | 0 | 555 |
| 2016 | 1 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 23 |
| 2018 | 0 | — | 3 | 37 |
| 2019 | 0 | — | 0 | 56 |
| 2020 | 1 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 33 |
| 2022 | 0 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 16 |
| 2024 | 0 | — | 0 | 18 |
| 2025 | 2 | — | 0 | 50 |
| 2026 | 0 | — | 4 | — |
https://510kreport.com/device/K002372 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002372: Access Alert Gauge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002372
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026