510(k) · Cleared
ClearedSight Saver All Purpose Lens Carrying Case
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Inc. · HPX Lens, Contact (Polymethylmethacrylate)
Cleared on Jul 31, 1985 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jul 31, 1985
- Review
- 56 days
- Class
- Class U
- Product code
- HPX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK852384 Sight Saver All Purpose Lens Carrying CaseBausch & Lomb, Inc. · 1985
- Descendant · cites it directly · 4 of its ownK013232 Cybercases by Bausch & LombBausch & Lomb, Inc. · 2001
- Descendant · 2 generations on · 0 of its ownK231123 Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix…Phoenix Innovative Healthcare Manufacturers Pvt., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK173365 Bausch + Lomb Boston Scleral Lens CaseBausch & Lomb, Incorporated · 2017
- Descendant · 2 generations on · 0 of its ownK040914 Polyvial/Polypak, Contact Lens Case and Storage System Container for…Exero Products, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK032309 Novelens Contact Lens Cleaning Enhancement and Storage AccessoryNovelens, Inc. · 2003
Most influential descendants
Showing 5 of 5 · See all- K013232Cybercases by Bausch & LombBausch & Lomb, Inc. · 2001 · cites it directly4descendants
- K231123Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case -…Phoenix Innovative Healthcare Manufacturers Pvt., Ltd. · 2023 · 2 generations on0descendants
- K173365Bausch + Lomb Boston Scleral Lens CaseBausch & Lomb, Incorporated · 2017 · 2 generations on0descendants
- K040914Polyvial/Polypak, Contact Lens Case and Storage System Container for OphthalmicsExero Products, Inc. · 2004 · 2 generations on0descendants
- K032309Novelens Contact Lens Cleaning Enhancement and Storage AccessoryNovelens, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K852384 | Sight Saver All Purpose Lens Carrying Case | Bausch & Lomb, Inc. | 1985 | — |
| +1 | K013232 | Cybercases by Bausch & Lomb | Bausch & Lomb, Inc. | 2001 | — |
| +2 | K231123 | Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens… | Phoenix Innovative Healthcare Manufacturers Pvt., Ltd. | 2023 | — |
| +2 | K173365 | Bausch + Lomb Boston Scleral Lens Case | Bausch & Lomb, Incorporated | 2017 | — |
| +2 | K040914 | Polyvial/Polypak, Contact Lens Case and Storage System Container for Ophthalmics | Exero Products, Inc. | 2004 | — |
| +1 | K032309 | Novelens Contact Lens Cleaning Enhancement and Storage Accessory | Novelens, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 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 HPX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K013232 (Bausch & Lomb, Inc., 2001) has gone furthest, with 4 descendants of its own.
How does its category compare?
All HPX devicesHPX Lens, Contact (Polymethylmethacrylate): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HPX
FDA has decided no HPX device since 2007.
Median 510(k) review, days · HPX
Too few HPX 510(k)s in any year since 2007 to give a median.
Recalls per year · HPX
No recall names HPX since 2007.
Adverse event reports per year · HPX
1in 2017
MAUDE reports naming product code HPX, 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 | 2 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K852384 · printed Nov 4, 2026
Cite this page
510(k) Report. “K852384: Sight Saver All Purpose Lens Carrying Case.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K852384
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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