510(k) · Cleared
ClearedFirefly Needleless Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puracath Medical, Inc. · FPA Set, Administration, Intravascular
Cleared on Jul 30, 2021 as substantially equivalent to K132413 (Care Fusion, 2013) after a 214-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it.
- Decided
- Jul 30, 2021
- Review
- 214 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K942988 (1995). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 5 generations backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
- 4 generations backK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
- 3 generations backK021692 CLC2000 Catheter Patency DeviceIcu Medical, Inc. · 2003
- 2 generations backK100434 Clave NeutronIcu Medical, Inc. · 2010 · Recalled
- 1 generation backK132413 MZ1000Care Fusion · 2013
- This deviceK203796 Firefly Needleless ConnectorPuracath Medical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK251375 PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | 32 |
| −5 | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | 27 |
| −4 | K973167 | Positive Pressure Connector | Icu Medical, Inc. | 1997 | — |
| −3 | K021692 | CLC2000 Catheter Patency Device | Icu Medical, Inc. | 2003 | — |
| −2 | K100434 | Clave Neutron | Icu Medical, Inc. | 2010 | 3 |
| −1 | K132413 | MZ1000 | Care Fusion | 2013 | — |
| 0 (this device) | K203796 | Firefly Needleless Connector | Puracath Medical, Inc. | 2021 | — |
| +1 | K251375 | PuraCath Firefly Needleless Connector IT (9005) | Puracath Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 FPA? 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K132413 | MZ1000Summary page 4…Product Code: FPA Predicate Device: CareFusion, MaxZero Needleless Connector, MZ1000 (K132413) 5.3. Device Description 5.3.1. Subject Device Overview The PuraCath Firefly Needleless Conne… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251375 | PuraCath Firefly Needleless Connector IT (9005) | 2026 | 0 |
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 26 years and passes through 5 companies; a new generation was cleared every 6.0 years on median.
- 8 of the 14 ancestors have a recall of any class.
- Of its descendants, K251375 (Puracath Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K132413.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The PuraCath™ Firefly™ Needleless Connector is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy and can be used for direct injection, intermittent infusion, continuous infusion or aspiration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203796: Firefly Needleless Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203796
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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