510(k) · Cleared
ClearedLight Drape
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrapped IN Comfort · MMP Cover, Barrier, Protective
Cleared on May 25, 2005 after a 184-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- May 25, 2005
- Review
- 184 days
- Class
- Class II
- Product code
- MMP
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK043234 Light DrapeWrapped IN Comfort · 2005
- Descendant · cites it directly · 0 of its ownK093618 Bili-Mirror Model BLM-1Physician Engineered Products, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K093618Bili-Mirror Model BLM-1Physician Engineered Products, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043234 | Light Drape | Wrapped IN Comfort | 2005 | — |
| +1 | K093618 | Bili-Mirror Model BLM-1 | Physician Engineered Products, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MMP? 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093618 | Bili-Mirror Model BLM-1 | 2010 | 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, K093618 (Physician Engineered Products, Inc., 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MMP devicesMMP Cover, Barrier, Protective: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MMP
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · MMP
Too few MMP 510(k)s in any year since 2007 to give a median.
Recalls per year · MMP
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MMP
1in 2025
MAUDE reports naming product code MMP, 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 | 0 |
| 2008 | 0 | — | 5 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 1 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Light Drapes are designed to cover and enhance the outer appearance of phototherapy light fixtures.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K043234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043234: Light Drape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043234
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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