510(k) · Cleared

Cleared

Astra Tech AB Lofric Primo Single Use Urinary Catheter

K050874510(k) SpecialCleared May 5, 200529-day reviewClass II21 CFR 876.5130

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Astra Tech, Inc. · GBM Catheter, Urethral

Cleared on May 5, 2005 as substantially equivalent to K896750 (Astra Meditec AB, 1990) after a 29-day review. Its family tree reaches back 1 generation to 1990. 33 later devices descend from it.

Decided: May 5, 2005
Review: 29 days
Class: Class II
Product code: GBM
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K896750 (1990). 33 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK896750 Lofric (R), Lofric (R) Cath-KitAstra Meditec AB · 1990
This deviceK050874 Astra Tech AB Lofric Primo Single Use Urinary CatheterAstra Tech, Inc. · 2005
Descendant · cites it directly · 15 of its ownK090960 Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142…Hollister, Inc. · 2009
Descendant · 2 generations on · 14 of its ownK110862 Vapro Plus Intermittent CatheterHollister Incorporated · 2011
Descendant · 2 generations on · 13 of its ownK141642 Vapro Intermittent CatheterHollister Incorporated · 2014
Descendant · 3 generations on · 6 of its ownK180824 VaPro 2 Intermittent CatheterHollister Incorporated · 2018
Descendant · cites it directly · 5 of its ownK062444 HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters…Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. · 2007

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2007high 5 (2022) · low 0 (2008)2026

Most influential descendants

Showing 5 of 33 · See all

K090960Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084…Hollister, Inc. · 2009 · cites it directly15descendants
K110862Vapro Plus Intermittent CatheterHollister Incorporated · 2011 · 2 generations on14descendants
K141642Vapro Intermittent CatheterHollister Incorporated · 2014 · 2 generations on13descendants
K180824VaPro 2 Intermittent CatheterHollister Incorporated · 2018 · 3 generations on6descendants
K062444HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and KitOasis Medikal Urunler Kimya Sanayi VE Tic A.S. · 2007 · cites it directly5descendants

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)	K050874	Astra Tech AB Lofric Primo Single Use Urinary Catheter	Astra Tech, Inc.	2005	—
+1	K090960	Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064…	Hollister, Inc.	2009	—
+2	K110862	Vapro Plus Intermittent Catheter	Hollister Incorporated	2011	—
+2	K141642	Vapro Intermittent Catheter	Hollister Incorporated	2014	—
+3	K180824	VaPro 2 Intermittent Catheter	Hollister Incorporated	2018	—
+1	K062444	HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and Kit	Oasis Medikal Urunler Kimya Sanayi VE Tic A.S.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2009	1	0
2011	1	0
2012	2	0
2014	3	0
2015	3	0
2016	2	0
2017	1	0
2018	3	0
2019	2	0
2022	5	0
2023	2	0
2024	2	0
2025	2	0
2026	3	0

FIG. 1 — Lineage of K050874, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K896750	Lofric (R), Lofric (R) Cath-Kit Summary page 1 …The modified LoFric Primo Single Use Urinary Catheter is substantially equivalent in intended use to the LoFric Single Use Urinary Catheter (K896750). 4. Device Description The LoFric Primo Single Use Urinary Catheter is designed as an intermittent pa…	Astra Meditec AB	1990	—

Also cleared against K896750: 5 other devices →

What descends from it? (33)

See all 33

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K090960	Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084…	Hollister, Inc.	2009	15
K062444	HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and Kit	Oasis Medikal Urunler Kimya Sanayi VE Tic A.S.	2007	5
K161344	GentleCath Glide Intermittent Catheter	Convatec Limited	2016	4
K181206	GentleCath Glide Intermittent Urinary Catheter	Convatec Limited	2018	3
K122078	Lofric Primo, Lofric Hydro-Kit	Astra Tech, Inc.	2012	2
K111405	Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip…	Hangzhou Bever Medical Devices Co., Ltd.	2012	2

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?

Its one ancestor has no recall.
Of its descendants, K090960 (Hollister, Inc., 2009) has gone furthest, with 15 descendants of its own.
5 other devices also cite its predicate K896750.

How does its category compare?

All GBM devices

GBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GBM

1in 2025

2007high 7 (2019) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GBM

230in 2020

2007high 230 (2020) · low 76 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GBM

1in 2025

2007high 5 (2008) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GBM

311in 2025

2007high 468 (2024) · low 3 (2009)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® PrimoTM Single Use Urinary Catheter is intended for intermittent catheterization of the urethra.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050874 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050874: Astra Tech AB Lofric Primo Single Use Urinary Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050874

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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