510(k) · Cleared
ClearedA P Harness
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paraworks Enterprise, Ltd. · KMK Device, Intravascular Catheter Securement
Cleared on Jun 3, 1999 after a 372-day review. The FDA summary names its predicate without a number.
- Decided
- Jun 3, 1999
- Review
- 372 days
- Class
- Class I
- Product code
- KMK
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 KMK? 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? (1)
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 |
|---|---|---|---|
| * | — | Baxter’s SiteLock™ Epidural Catheter Securement Device Named without a submission number |
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.
How does its category compare?
All KMK devicesKMK Device, Intravascular Catheter Securement: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMK
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · KMK
Too few KMK 510(k)s in any year since 2007 to give a median.
Recalls per year · KMK
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMK
75in 2025
MAUDE reports naming product code KMK, 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 | — | 3 | 1 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 18 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 0 | — | 2 | 19 |
| 2017 | 0 | — | 0 | 45 |
| 2018 | 0 | — | 0 | 40 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 33 |
| 2022 | 0 | — | 0 | 103 |
| 2023 | 0 | — | 0 | 138 |
| 2024 | 0 | — | 0 | 104 |
| 2025 | 0 | — | 0 | 75 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AP Harness is to be used as a safety line between a patient and a medical machine which are connected by a medical line, (ie IV tubing, oxygen tubing, enteral tubing, etc. ). This device would be used when the patient or caregiver cannot maintain an adequate level of safety for an important catheter or other medical line.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981860 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981860: A P Harness.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981860
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026