510(k) · Cleared
Recalled · Class II · 2020Lofric Primo, Lofric Hydro-Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astra Tech, Inc. · EZD Catheter, Straight
Cleared on Oct 31, 2012 as substantially equivalent to K113424 (Astra Tech AB, 2012) and 2 other predicates after a 107-day review. Its family tree reaches back 2 generations to 1990. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 31, 2012
- Review
- 107 days
- Class
- Class II
- Product code
- EZD
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 2 generations to K896750 (1990). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK896750 Lofric (R), Lofric (R) Cath-KitAstra Meditec AB · 1990
- 1 generation backK043241 Lofric Hydro-Kit II Single Use Urinary CatheterAstra Tech, Inc. · 2004
- This deviceK122078 Lofric Primo, Lofric Hydro-KitAstra Tech, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK250659 LoFric OrigoWellspect AB · 2025
- Descendant · 2 generations on · 0 of its ownK261658 LoFric Origo Pro CoudéWellspect AB · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896750 | Lofric (R), Lofric (R) Cath-Kit | Astra Meditec AB | 1990 | — |
| −1 | K043241 | Lofric Hydro-Kit II Single Use Urinary Catheter | Astra Tech, Inc. | 2004 | — |
| 0 (this device) | K122078 | Lofric Primo, Lofric Hydro-Kit | Astra Tech, Inc. | 2012 | — |
| +1 | K250659 | LoFric Origo | Wellspect AB | 2025 | — |
| +2 | K261658 | LoFric Origo Pro Coudé | Wellspect AB | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 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 EZD? 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 EZD device
- #1 K241210 Luja Coudescore 16.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K113424 | Lofric Single Use Urinary Catheter | 2012 |
| * | K043241 | Lofric Hydro-Kit II Single Use Urinary CatheterSummary page 2…ted predicate devices: Astra Tech AB, LoFric* Single Use Urinary Catheter 7- Kl 13424 Astra Tech, Inc., Astra Tech AB LoFric" Hydro-Kit 11 Single Use Urinary Catheter - K043241 Astra Tech, Inc., Astra Tech AB LoFrico PrimOTM Single Use Urinary Catheter - K050874 The subject devices and the predicate devi… | 2004 |
| * | K050874 | Astra Tech AB Lofric Primo Single Use Urinary CatheterSummary page 2…Astra Tech, Inc., Astra Tech AB LoFric" Hydro-Kit 11 Single Use Urinary Catheter - K043241 Astra Tech, Inc., Astra Tech AB LoFrico PrimOTM Single Use Urinary Catheter - K050874 The subject devices and the predicate device have the same intended use, which is for intermittent urinary catheterization. All… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250659 | LoFric Origo | 2025 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 17, 2020 | Class II | Z-2643-2020 | Equipment maintenance | Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheter s distal tip. |
| Jun 17, 2020 | Class II | Z-2644-2020 | Equipment maintenance | Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip. |
| Jun 17, 2020 | Class II | Z-2645-2020 | Equipment maintenance | Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 14.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K250659 (Wellspect AB, 2025) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · EZD
11so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · EZD
130in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZD
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZD
288in 2025
MAUDE reports naming product code EZD, 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 | 4 | 121 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 4 |
| 2010 | 2 | — | 0 | 6 |
| 2011 | 4 | 116 | 1 | 4 |
| 2012 | 2 | — | 1 | 2 |
| 2013 | 4 | 110 | 0 | 18 |
| 2014 | 5 | 91 | 1 | 17 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 3 | 83 | 0 | 21 |
| 2017 | 2 | — | 0 | 120 |
| 2018 | 3 | 122 | 0 | 390 |
| 2019 | 0 | — | 0 | 466 |
| 2020 | 1 | — | 0 | 563 |
| 2021 | 0 | — | 0 | 994 |
| 2022 | 10 | 288 | 0 | 487 |
| 2023 | 6 | 214 | 0 | 553 |
| 2024 | 5 | 147 | 0 | 116 |
| 2025 | 6 | 130 | 0 | 288 |
| 2026 | 11 | 146 | 0 | — |
What is it indicated for?
LoFric® PrimoTM and LoFric® Hydro-KitTm are intended for intermittent urinary catheterization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122078: Lofric Primo, Lofric Hydro-Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122078
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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