510(k) · Cleared
ClearedPolyvial/Polypak, Contact Lens Case and Storage System Container for Ophthalmics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exero Products, Inc. · LRX Case, Contact Lens
Cleared on May 27, 2004 as substantially equivalent to K971618 (Alcon Laboratories, 1997) and 5 other predicates after a 49-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- May 27, 2004
- Review
- 49 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K951552 (1995). 12 ancestors in all, the oldest K852384 (1985). No later device cites it as a predicate yet.
- Root · 4 generations backK951552 Boston Contact Lens CasePolymer Technology Corp. · 1995
- 3 generations backK962512 Boston Contact Lens CasePolymer Technology Div. Wilmington Partners, L.P. · 1996
- 2 generations backK974635 Paragon Lens CareParagon Vision Sciences · 1998
- 1 generation backK993486 Paragon Lens CarrierParagon Vision Sciences · 1999
- This deviceK040914 Polyvial/Polypak, Contact Lens Case and Storage System Container for…Exero Products, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951552 | Boston Contact Lens Case | Polymer Technology Corp. | 1995 | — |
| −3 | K962512 | Boston Contact Lens Case | Polymer Technology Div. Wilmington Partners, L.P. | 1996 | — |
| −2 | K974635 | Paragon Lens Care | Paragon Vision Sciences | 1998 | — |
| −1 | K993486 | Paragon Lens Carrier | Paragon Vision Sciences | 1999 | — |
| 0 (this device) | K040914 | Polyvial/Polypak, Contact Lens Case and Storage System Container for Ophthalmics | Exero Products, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 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 LRX? 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 LRX device
- #1 K240095 CAREUS Contact Lens Case (Model 1, Model 2…score 15.4 · 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? (6)
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 |
|---|---|---|---|
| * | K971618 | Alcon Contact Lens CaseSummary page 2…Pred'catedevices : Aicon Coatact, Lens Case Manufactured/distributed by Alcon Laboratories. 510(k) number; K971618 Alcon Contact Lens Case Man faCtured/distributed by Alcon Laboratories… | 1997 |
| * | K974281 | Alcon Contact Lens CaseSummary page 2…8 Alcon Contact Lens Case Man faCtured/distributed by Alcon Laboratories 510'k) number: K974281 aragon L~ens Carrier Manutcaured/distributed by Paragon Vision Sciences.… | 1998 |
| * | K993486 | Paragon Lens CarrierSummary page 2…aragon L~ens Carrier Manutcaured/distributed by Paragon Vision Sciences. 5 t0(k).number; K993486, K993487 Paragon Contact Lens Case Manufactured/distributed by Paragon Vis… | 1999 |
| * | K993487 | Paragon Lens VialSummary page 2…aragon L~ens Carrier Manutcaured/distributed by Paragon Vision Sciences. 5 t0(k).number; K993486, K993487 Paragon Contact Lens Case Manufactured/distributed by Paragon Vision Scien… | 1999 |
| * | K013232 | Cybercases by Bausch & LombSummary page 2…miumber: K993486 CWhberCases MAjwfcturec.djstribtaed by Bausch & Lomb. 51.'I(k) number. K013232 #-90(WG (Lens Vial w! gasket and cap) Manufactureci/distributed by Pelican… | 2001 |
| * | K030987 | Contact Lens Storage CaseSummary page 2…#-90(WG (Lens Vial w! gasket and cap) Manufactureci/distributed by Pelican Products, Inc. 510(k) number; K030987 Device Description: ThePolyVial /PolyPa4 by Exero Products consists of a polypropylene body, polypropylene cap, with an integr… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 12 ancestors has a recall.
- 2 other devices also cite its predicate K971618.
How does its category compare?
All LRX devicesLRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LRX
49in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRX
No recall names LRX since 2007.
Adverse event reports per year · LRX
1in 2021
MAUDE reports naming product code LRX, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 3 | 103 | 0 | 1 |
| 2013 | 4 | 72 | 0 | 0 |
| 2014 | 3 | 249 | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 5 | 49 | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
PolyVial/ PolyPak Contact Lens Case storage system by Exero .Products is indicated for storage of hard, RGP (Rigid Gas Permeable) fitro silicone acylate and silicone acrylate and Soft (bydrophilic) contact lenses during chemical disinfection
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040914 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040914: Polyvial/Polypak, Contact Lens Case and Storage System Container for Ophthalmics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040914
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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