510(k) Report

510(k) · Cleared

Cleared

Lofric Hydro-Kit II Single Use Urinary Catheter

K043241510(k) SpecialCleared Dec 23, 200430-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 Dec 23, 2004 as substantially equivalent to K896750 (Astra Meditec AB, 1990) after a 30-day review. Its family tree reaches back 1 generation to 1990. 9 later devices descend from it.

Decided
Dec 23, 2004
Review
30 days
Class
Class II
Product code
GBM
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K896750 (1990). 9 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2012: 1 descendant cleared2022: 1 descendant cleared2014: 2 descendants cleared2023: 2 descendants cleared2025: 1 descendant cleared2026: 1 descendant clearedK896750 · Lofric (R), Lofric (R) Cath-Kit · Astra Meditec AB · 19901990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants K896750 · Lofric (R), Lofric (R) Cath-Kit · Astra Meditec AB · 19900
  1. Root · 1 generation backK896750 Lofric (R), Lofric (R) Cath-KitAstra Meditec AB · 1990
  2. This deviceK043241 Lofric Hydro-Kit II Single Use Urinary CatheterAstra Tech, Inc. · 2004
  3. 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
  4. Descendant · 2 generations on · 2 of its ownK133615 Well Lead PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd. · 2014
  5. Descendant · cites it directly · 2 of its ownK122078 Lofric Primo, Lofric Hydro-KitAstra Tech, Inc. · 2012 · Recalled
  6. Descendant · 2 generations on · 1 of its ownK250659 LoFric OrigoWellspect AB · 2025
  7. Descendant · 3 generations on · 0 of its ownK261658 LoFric Origo Pro CoudéWellspect AB · 2026

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2007: 12012: 12014: 22022: 12023: 22025: 12026: 1
2007high 2 (2014) · low 0 (2008)2026

Most influential descendants

Showing 5 of 9 · See all
  • 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
  • K133615Well Lead PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd. · 2014 · 2 generations on2descendants
  • K122078Lofric Primo, Lofric Hydro-KitAstra Tech, Inc. · 2012 · cites it directly2descendants
  • K250659LoFric OrigoWellspect AB · 2025 · 2 generations on1descendant
  • K261658LoFric Origo Pro CoudéWellspect AB · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K896750Lofric (R), Lofric (R) Cath-KitAstra Meditec AB1990—
0 (this device)K043241Lofric Hydro-Kit II Single Use Urinary CatheterAstra Tech, Inc.2004—
+1K062444HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and KitOasis Medikal Urunler Kimya Sanayi VE Tic A.S.2007—
+2K133615Well Lead PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd.2014—
+1K122078Lofric Primo, Lofric Hydro-KitAstra Tech, Inc.20123
+2K250659LoFric OrigoWellspect AB2025—
+3K261658LoFric Origo Pro CoudéWellspect AB2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201210
201420
202210
202320
202510
202610
FIG. 1 — Lineage of K043241, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241734 Wellead® Hydrophilic Intermittent Catheter…score 10.2 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K896750Lofric (R), Lofric (R) Cath-Kit
Summary page 1
…dified The LoFric® Hydro-Kit II Single Use Urinary Catheter is substantially equivalent in intended use to the LoFric® Single Use Urinary Catheter (K896750). 4. Device Description The LoFric® Hydro-Kit II Single Use Urinary Catheter is designed as an intermit…
Astra Meditec AB1990—

Also cleared against K896750: 5 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K062444HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and KitOasis Medikal Urunler Kimya Sanayi VE Tic A.S.20075
K122078Lofric Primo, Lofric Hydro-KitAstra Tech, Inc.20122

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, K062444 (Oasis Medikal Urunler Kimya Sanayi VE Tic A.S., 2007) has gone furthest, with 5 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

2007: 22009: 12011: 22012: 32014: 12015: 52016: 32017: 22018: 62019: 72020: 62022: 22025: 1
2007high 7 (2019) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GBM

230in 2020

2012: 139 days median2015: 76 days median2016: 112 days median2018: 93 days median2019: 121 days median2020: 230 days median
2007high 230 (2020) · low 76 (2015)2026

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

Recalls per year · GBM

1in 2025

2008: 52011: 12023: 1, 1 Class I2025: 12026 (partial year): 1
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

2007: 52008: 182009: 32010: 332011: 462012: 322013: 412014: 192015: 212016: 492017: 592018: 822019: 1482020: 1442021: 1022022: 2832023: 2022024: 4682025: 311
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—05
20080—518
20091—03
20100—033
20112—146
20123139032
20130—041
20141—019
2015576021
20163112049
20172—059
2018693082
201971210148
202062300144
20210—0102
20222—0283
20230—1 (1)202
20240—0468
20251—1311
20260—1—

What is it indicated for?

The LoFric® Hydro-Kit II Single Use Urinary Catheter is intended for intermittent catheterization of the urethra.

Indications for use as stated in the FDA summary.

Also cleared against K896750

5 other devices cite the same predicate.

  • K113424Lofric Single Use Urinary CatheterAstra Tech AB · 2012
  • K062444HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and KitOasis Medikal Urunler Kimya Sanayi VE Tic A.S. · 2007
  • K050874Astra Tech AB Lofric Primo Single Use Urinary CatheterAstra Tech, Inc. · 2005
  • K023254SpeedicathColoplast Corp. · 2003
  • K012374Modification to: Lofric Plus Single Use Urinary CatheterAstra Tech, Inc. · 2001

More from Astra Tech, Inc.

28 FDA decisions under this applicant name. See the company

  • K122078Lofric Primo, Lofric Hydro-KitAstra Tech, Inc. · 20123 recalls
  • K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc. · 2012
  • K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant, Atlantis Gemini (TM)…Astra Tech, Inc. · 2012
  • K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
  • K110640Atlantis Abutment for Camlog Implant, Duplicate Abutment, Later AbutmentAstra Tech, Inc. · 2011

Recent decisions in GBM

The GBM category page

  • K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd. · 2025
  • K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited · 2022
  • K211436Intermittent Catheter (Not Finalized)Hollister Incorporated · 20221 recall
  • K200820SpeediCath Compact SetColoplast · 2020
  • K192904SpeediCath Compact SetColoplast · 2020

https://510kreport.com/device/K043241 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043241: Lofric Hydro-Kit II 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/K043241

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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