510(k) · Cleared
ClearedSwabbable Cap, Model 60205
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxa Corp. · ODI Administration Set Docking Station
Cleared on Aug 3, 2007 as substantially equivalent to K981318 (Baxter Healthcare Corp, 1998) after a 198-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Aug 3, 2007
- Review
- 198 days
- Class
- Class II
- Product code
- ODI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981318 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK981318 Dual Luer Lock CapBaxter Healthcare Corp · 1998
- This deviceK070163 Swabbable Cap, Model 60205Baxa Corp. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981318 | Dual Luer Lock Cap | Baxter Healthcare Corp | 1998 | — |
| 0 (this device) | K070163 | Swabbable Cap, Model 60205 | Baxa Corp. | 2007 | — |
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 ODI? 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 |
|---|---|---|---|
| * | K981318 | Dual Luer Lock CapSummary page 1…Set (Class II)(FPA) Manufacturer: Baxter Healthcare Corporation 510(k) Number: K981318 Product Description: Provides temporary aseptic closure of the male luer c… | 1998 |
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.
- 2 other devices also cite its predicate K981318.
How does its category compare?
All ODI devicesODI Administration Set Docking Station: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · ODI
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · ODI
Too few ODI 510(k)s in any year since 2007 to give a median.
Recalls per year · ODI
No recall names ODI since 2007.
Adverse event reports per year · ODI
No MAUDE report names ODI since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 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?
The Swabbable Cap provides temporary aseptic closure of the male luer connector of the IV tubing while disconnected from the patient, replacing the need for disposable caps to maintain aseptic procedure. The device is designed to be permanently attached to an IV administration set and used over the life of the administration set.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070163 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070163: Swabbable Cap, Model 60205.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070163
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