510(k) · Cleared
ClearedLofric (R), Lofric (R) Cath-Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astra Meditec AB · KOD Catheter, Urological
Cleared on Aug 6, 1990 after a 249-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 69 later devices descend from it.
- Decided
- Aug 6, 1990
- Review
- 249 days
- Class
- Class II
- Product code
- KOD
- Recalls
- None
- Predicates
- 0
69 later devices descend from it, 6 citing it directly.
- This deviceK896750 Lofric (R), Lofric (R) Cath-KitAstra Meditec AB · 1990
- Descendant · cites it directly · 54 of its ownK012374 Modification to: Lofric Plus Single Use Urinary CatheterAstra Tech, Inc. · 2001
- Descendant · cites it directly · 53 of its ownK023254 SpeedicathColoplast Corp. · 2003
- Descendant · cites it directly · 33 of its ownK050874 Astra Tech AB Lofric Primo Single Use Urinary CatheterAstra Tech, Inc. · 2005
- 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
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- K012374Modification to: Lofric Plus Single Use Urinary CatheterAstra Tech, Inc. · 2001 · cites it directly54descendants
- K023254SpeedicathColoplast Corp. · 2003 · cites it directly53descendants
- K050874Astra Tech AB Lofric Primo Single Use Urinary CatheterAstra Tech, Inc. · 2005 · cites it directly33descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K896750 | Lofric (R), Lofric (R) Cath-Kit | Astra Meditec AB | 1990 | — |
| +1 | K012374 | Modification to: Lofric Plus Single Use Urinary Catheter | Astra Tech, Inc. | 2001 | — |
| +1 | K023254 | Speedicath | Coloplast Corp. | 2003 | — |
| +1 | K050874 | Astra Tech AB Lofric Primo Single Use Urinary Catheter | Astra Tech, Inc. | 2005 | — |
| +2 | K090960 | Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064… | Hollister, Inc. | 2009 | — |
| +3 | K110862 | Vapro Plus Intermittent Catheter | Hollister Incorporated | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KOD? 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 KOD device
- #1 K251864 Rubber Utility Catheterscore 10.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (69)
See all 696 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012374 | Modification to: Lofric Plus Single Use Urinary Catheter | 2001 | 54 |
| K023254 | Speedicath | 2003 | 53 |
| K050874 | Astra Tech AB Lofric Primo Single Use Urinary Catheter | 2005 | 33 |
| K043241 | Lofric Hydro-Kit II Single Use Urinary Catheter | 2004 | 9 |
| K062444 | HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and Kit | 2007 | 5 |
| K113424 | Lofric Single Use Urinary Catheter | 2012 | 3 |
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?
- Of its descendants, K012374 (Astra Tech, Inc., 2001) has gone furthest, with 54 descendants of its own.
How does its category compare?
All KOD devicesKOD Catheter, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOD
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · KOD
251in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KOD
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KOD
1,389in 2025
MAUDE reports naming product code KOD, 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 | 180 |
| 2008 | 2 | — | 0 | 102 |
| 2009 | 1 | — | 15 | 183 |
| 2010 | 1 | — | 1 | 228 |
| 2011 | 2 | — | 47 | 209 |
| 2012 | 0 | — | 2 | 165 |
| 2013 | 0 | — | 0 | 393 |
| 2014 | 1 | — | 0 | 226 |
| 2015 | 0 | — | 0 | 418 |
| 2016 | 2 | — | 1 | 284 |
| 2017 | 1 | — | 0 | 1,873 |
| 2018 | 6 | 251 | 0 | 1,179 |
| 2019 | 1 | — | 1 | 1,167 |
| 2020 | 0 | — | 0 | 1,370 |
| 2021 | 1 | — | 0 | 1,388 |
| 2022 | 2 | — | 3 | 1,280 |
| 2023 | 0 | — | 1 (1) | 1,160 |
| 2024 | 0 | — | 0 | 1,259 |
| 2025 | 0 | — | 0 | 1,389 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K896750 · printed Nov 4, 2026
Cite this page
510(k) Report. “K896750: Lofric (R), Lofric (R) Cath-Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K896750
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026