510(k) · Cleared
ClearedModification to: Lofric Plus Single Use Urinary Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astra Tech, Inc. · GBM Catheter, Urethral
Cleared on Aug 23, 2001 as substantially equivalent to K896750 (Astra Meditec AB, 1990) after a 28-day review. Its family tree reaches back 1 generation to 1990. 54 later devices descend from it.
- Decided
- Aug 23, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- GBM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K896750 (1990). 54 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK896750 Lofric (R), Lofric (R) Cath-KitAstra Meditec AB · 1990
- This deviceK012374 Modification to: Lofric Plus Single Use Urinary CatheterAstra Tech, Inc. · 2001
- Descendant · cites it directly · 53 of its ownK023254 SpeedicathColoplast Corp. · 2003
- Descendant · 2 generations on · 15 of its ownK090960 Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142…Hollister, Inc. · 2009
- Descendant · 3 generations on · 14 of its ownK110862 Vapro Plus Intermittent CatheterHollister Incorporated · 2011
- Descendant · 3 generations on · 13 of its ownK141642 Vapro Intermittent CatheterHollister Incorporated · 2014
- Descendant · 2 generations on · 12 of its ownK072808 Speedicath CompactColoplast Corp. · 2007
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K023254SpeedicathColoplast Corp. · 2003 · cites it directly53descendants
- K090960Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084…Hollister, Inc. · 2009 · 2 generations on15descendants
- K110862Vapro Plus Intermittent CatheterHollister Incorporated · 2011 · 3 generations on14descendants
- K141642Vapro Intermittent CatheterHollister Incorporated · 2014 · 3 generations on13descendants
- K072808Speedicath CompactColoplast Corp. · 2007 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896750 | Lofric (R), Lofric (R) Cath-Kit | Astra Meditec AB | 1990 | — |
| 0 (this device) | K012374 | Modification to: Lofric Plus Single Use Urinary Catheter | Astra Tech, Inc. | 2001 | — |
| +1 | K023254 | Speedicath | Coloplast Corp. | 2003 | — |
| +2 | K090960 | Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064… | Hollister, Inc. | 2009 | — |
| +3 | K110862 | Vapro Plus Intermittent Catheter | Hollister Incorporated | 2011 | — |
| +3 | K141642 | Vapro Intermittent Catheter | Hollister Incorporated | 2014 | — |
| +2 | K072808 | Speedicath Compact | Coloplast Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 GBM? 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 GBM device
- #1 K241734 Wellead® Hydrophilic Intermittent Catheter…score 10.2 · 5 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 |
|---|---|---|---|
| * | K896750 | Lofric (R), Lofric (R) Cath-KitSummary page 1…egally Marketed Device The modified The LoFric® Plus Single Use Urinary Catheter is substantially equivalent in intended use to the LoFric® Single Use Urinary Catheter (K896750). Device Description The LoFric® Plus Single Use Urinary Catheter is designed as an intermittent pathway for drainage of the bla… | 1990 |
What descends from it? (54)
See all 542 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GBM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GBM
230in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GBM
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GBM
311in 2025
MAUDE reports naming product code GBM, 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 | 2 | — | 0 | 5 |
| 2008 | 0 | — | 5 | 18 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 2 | — | 1 | 46 |
| 2012 | 3 | 139 | 0 | 32 |
| 2013 | 0 | — | 0 | 41 |
| 2014 | 1 | — | 0 | 19 |
| 2015 | 5 | 76 | 0 | 21 |
| 2016 | 3 | 112 | 0 | 49 |
| 2017 | 2 | — | 0 | 59 |
| 2018 | 6 | 93 | 0 | 82 |
| 2019 | 7 | 121 | 0 | 148 |
| 2020 | 6 | 230 | 0 | 144 |
| 2021 | 0 | — | 0 | 102 |
| 2022 | 2 | — | 0 | 283 |
| 2023 | 0 | — | 1 (1) | 202 |
| 2024 | 0 | — | 0 | 468 |
| 2025 | 1 | — | 1 | 311 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The LoFric® Plus Single Use Urinary Catheter is intended
for intermittent catheterization of the urethra.
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/K012374 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012374: Modification to: Lofric Plus Single Use Urinary Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012374
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026