510(k) · Cleared

Cleared

Lifestyle Break Thru (Polymacon)

K965012510(k) TraditionalCleared Mar 11, 199785-day reviewClass II21 CFR 886.5925

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

The Lifestyle Co., Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Mar 11, 1997 after an 85-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided: Mar 11, 1997
Review: 85 days
Class: Class II
Product code: LPL
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK965012 Lifestyle Break Thru (Polymacon)The Lifestyle Co., Inc. · 1997
Descendant · cites it directly · 0 of its ownK110452 Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue…Unilens Corp., USA · 2011

Most influential descendants

Showing 1 of 1 · See all

K110452Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue Aquaflex Mto, Unilens…Unilens Corp., USA · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K965012	Lifestyle Break Thru (Polymacon)	The Lifestyle Co., Inc.	1997	—
+1	K110452	Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue Aquaflex Mto…	Unilens Corp., USA	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K965012, 1997–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 LPL? 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 LPL device

#1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
#2 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K110452	Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue Aquaflex Mto, Unilens…	Unilens Corp., USA	2011	0

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, K110452 (Unilens Corp., USA, 2011) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LPL devices

LPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPL

12in 2025

2007high 21 (2016) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPL

202in 2025

2007high 281 (2007) · low 56 (2018)2026

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

Recalls per year · LPL

1in 2025

2007high 11 (2017) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPL

216in 2025

2007high 377 (2011) · low 110 (2021)2025

MAUDE reports naming product code LPL, 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	3	281	1	280
2008	10	104	0	214
2009	6	260	1	137
2010	9	244	0	222
2011	12	170	5	377
2012	12	131	1	250
2013	17	135	0	151
2014	15	102	1	179
2015	12	120	1	161
2016	21	112	0	193
2017	9	98	11	280
2018	21	56	0	257
2019	11	115	0	205
2020	10	158	1	117
2021	8	88	0	110
2022	9	212	1	126
2023	10	167	0	178
2024	12	128	0	297
2025	12	202	1	216
2026	10	90	1	—

https://510kreport.com/device/K965012 · printed Nov 4, 2026

Cite this page

510(k) Report. “K965012: Lifestyle Break Thru (Polymacon).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965012

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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