510(k) · Cleared
ClearedFirefly Peritoneal Dialysis Connector Disinfection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puracath Medical, Inc. · KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Cleared on Jan 20, 2016 as substantially equivalent to K883239 (Baxter Healthcare Corp, 1988) and 1 other predicate after a 218-day review. Its family tree reaches back 6 generations to 2003.
- Decided
- Jan 20, 2016
- Review
- 218 days
- Class
- Class II
- Product code
- KDJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K030467 (2003). 10 ancestors in all, the oldest K833182 (1983). No later device cites it as a predicate yet.
- Root · 6 generations backK030467 Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller…Iv Medical, Inc. · 2003
- 5 generations backK063239 Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models…Hospira, Inc. · 2006 · Recalled
- 4 generations backK080579 Effectiv (TM) CapHospira, Inc. · 2008
- 3 generations backK083508 SwabcapExcelsior Medical Corp. · 2009
- 2 generations backK093229 Catheter Connections DualcapCatheter Connections, Inc. · 2010
- 1 generation backK142806 DualCapCatheter Connections, Inc. · 2015
- This deviceK151620 Firefly Peritoneal Dialysis Connector Disinfection SystemPuracath Medical, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K030467 | Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set | Iv Medical, Inc. | 2003 | — |
| −5 | K063239 | Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528… | Hospira, Inc. | 2006 | 7 |
| −4 | K080579 | Effectiv (TM) Cap | Hospira, Inc. | 2008 | — |
| −3 | K083508 | Swabcap | Excelsior Medical Corp. | 2009 | — |
| −2 | K093229 | Catheter Connections Dualcap | Catheter Connections, Inc. | 2010 | — |
| −1 | K142806 | DualCap | Catheter Connections, Inc. | 2015 | — |
| 0 (this device) | K151620 | Firefly Peritoneal Dialysis Connector Disinfection System | Puracath Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1998 | 1 | 0 |
| 2008 | 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 KDJ? 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 KDJ device
- #1 K250404 stay•safe® catheter extension set with Safe-…score 9.4 · 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K883239 | Capd Ultraviolet (U.V.) Germicidal Exchange Dev SysSummary page 5…n micro-organisms. The PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System may be used in the home or a healthcare facility. Predicate Device(s): 1) K883239, Baxter healthcare, CAPD UV Germicidal Exchange Dev System… | 1988 |
| * | K142806 | DualCapSummary page 6…care, CAPD UV Germicidal Exchange Dev System K151620 page 3/4 2) K142806, Catheter Connection, DualCap Disinfectant Cap The Indications for Use statement for PuraCath Firefly Peritoneal Dialysis Connec… | 2015 |
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 13 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K883239.
How does its category compare?
All KDJ devicesKDJ Set, Administration, For Peritoneal Dialysis, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · KDJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KDJ
90in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KDJ
21in 2024
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · KDJ
2,460in 2025
MAUDE reports naming product code KDJ, 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 | 219 |
| 2008 | 1 | — | 0 | 411 |
| 2009 | 0 | — | 2 | 233 |
| 2010 | 0 | — | 0 | 1,879 |
| 2011 | 0 | — | 0 | 4,315 |
| 2012 | 0 | — | 0 | 4,294 |
| 2013 | 1 | — | 1 | 5,623 |
| 2014 | 0 | — | 0 | 7,680 |
| 2015 | 2 | — | 1 | 6,870 |
| 2016 | 1 | — | 0 | 7,045 |
| 2017 | 0 | — | 0 | 4,636 |
| 2018 | 3 | 90 | 0 | 3,379 |
| 2019 | 1 | — | 0 | 2,456 |
| 2020 | 0 | — | 1 | 2,870 |
| 2021 | 0 | — | 0 | 3,167 |
| 2022 | 1 | — | 12 | 2,927 |
| 2023 | 0 | — | 1 | 2,947 |
| 2024 | 1 | — | 21 (10) | 3,113 |
| 2025 | 1 | — | 0 | 2,460 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PuraCath™ Firefly™ Peritoneal Dialysis Connector Disinfecting System is intended for use by PD (peritoneal dialysis) patients as a method of controlling air and touch contamination while performing a solution exchange. The PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System is comprised of Firefly™ UV Purification Device, Firefly™ Transfer Catheter, Firefly™ Luer Cover, and Firefly™ 99% IPA bottle. The effectiveness of the PuraCath…
Read the full statement (113 words)
The PuraCath™ Firefly™ Peritoneal Dialysis Connector Disinfecting System is intended for use by PD (peritoneal dialysis) patients as a method of controlling air and touch contamination while performing a solution exchange.
The PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System is comprised of Firefly™ UV Purification Device, Firefly™ Transfer Catheter, Firefly™ Luer Cover, and Firefly™ 99% IPA bottle.
The effectiveness of the PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Streptococcus pneumoniae, Methicillin-resistant Staphylococcus aureus, and Candida albicans yielding > 4log reduction in micro-organisms.
The PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System may be used in the home or a healthcare facility.
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/K151620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151620: Firefly Peritoneal Dialysis Connector Disinfection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151620
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