510(k) · Cleared
ClearedCutaneous Compression Device for Use in Hemodialysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Robert R. Stevens · KOC Accessories, Blood Circuit, Hemodialysis
Cleared on Jan 30, 1997 as substantially equivalent to K955270 (Robert R. Stevens, 1996) after a 114-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jan 30, 1997
- Review
- 114 days
- Class
- Class II
- Product code
- KOC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K955270 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK955270 Tape & Bandage, AdhesiveRobert R. Stevens · 1996
- This deviceK964041 Cutaneous Compression Device for Use in HemodialysisRobert R. Stevens · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955270 | Tape & Bandage, Adhesive | Robert R. Stevens | 1996 | — |
| 0 (this device) | K964041 | Cutaneous Compression Device for Use in Hemodialysis | Robert R. Stevens | 1997 | — |
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 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K955270 | Tape & Bandage, AdhesiveSummary page 1…ety, effectiveness, and intended use: Product: Cutaneous Compression Device for General Hospital Use Manufacturer: Concurrent Device Manufacturing, Inc. 510(k) Number: K955270 Substantial Equivalence Date: August 8, 1996 Product: Cutaneous Compression Device for Use in Hemodialysis Manufacturer: Concu… | 1996 |
| Kept off the family tree | K951973 | Cutaneous Compression Device for Use in Hemodialysis Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…ntial Equivalence Date: August 8, 1996 Product: Cutaneous Compression Device for Use in Hemodialysis Manufacturer: Concurrent Device Manufacturing, Inc. 510(k) Number: K951973 Substantial Equivalence Date: Determined to be Class I Exempt device under 21 C.F.R. § 876.5820, as evidenced by letter from Lil… |
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?
- Its one ancestor has no recall.
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/K964041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964041: Cutaneous Compression Device for Use in Hemodialysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964041
Report an extraction error
Are you the manufacturer?
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