510(k) · Cleared
ClearedLumex Air
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumex, Inc. · FNM Mattress, Air Flotation, Alternating Pressure
Cleared on Jan 10, 1997 as substantially equivalent to K923977 (Lumex, Inc., 1993) and 1 other predicate after a 119-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jan 10, 1997
- Review
- 119 days
- Class
- Class II
- Product code
- FNM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K923977 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK923977 Akrotech 4000Lumex, Inc. · 1993
- This deviceK963674 Lumex AirLumex, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923977 | Akrotech 4000 | Lumex, Inc. | 1993 | — |
| 0 (this device) | K963674 | Lumex Air | Lumex, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 FNM? 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K950513 | FDA’s K950513 is Archivemanager Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1995 |
| * | K923977 | Akrotech 4000Summary page 1…(k) status and evidence of this is copied in Appendix IV, reference K952610, dated September 7, 1995, by Timothy A. Ulatowski, Acting Director, Pilot Division; reference K923977, dated September 4, 1992, by Paul R. Beninger, M.D., Acting Director, General and Restorative Devices Division respectively. | 1993 |
| * | K952610 | Plexus/3000 (P/3000), Plexus/3500 (P/3500)Summary page 1…e. Please note that both the LUMEX/Plexus 3000® and the LUMEX/Akrotech 4000® have already received 510(k) status and evidence of this is copied in Appendix IV, reference K952610, dated September 7, 1995, by Timothy A. Ulatowski, Acting Director, Pilot Division; reference K923977, dated September 4, 1992, b… | 1995 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K923977.
How does its category compare?
All FNM devicesFNM Mattress, Air Flotation, Alternating Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FNM
FDA has decided no FNM device since 2007.
Median 510(k) review, days · FNM
Too few FNM 510(k)s in any year since 2007 to give a median.
Recalls per year · FNM
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FNM
128in 2025
MAUDE reports naming product code FNM, 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 | 33 |
| 2008 | 0 | — | 4 | 35 |
| 2009 | 0 | — | 0 | 33 |
| 2010 | 0 | — | 1 | 56 |
| 2011 | 0 | — | 0 | 291 |
| 2012 | 0 | — | 0 | 303 |
| 2013 | 0 | — | 0 | 223 |
| 2014 | 0 | — | 0 | 80 |
| 2015 | 0 | — | 0 | 80 |
| 2016 | 0 | — | 0 | 50 |
| 2017 | 0 | — | 0 | 56 |
| 2018 | 0 | — | 0 | 115 |
| 2019 | 0 | — | 0 | 101 |
| 2020 | 0 | — | 0 | 58 |
| 2021 | 0 | — | 0 | 47 |
| 2022 | 0 | — | 0 | 75 |
| 2023 | 0 | — | 0 | 197 |
| 2024 | 0 | — | 0 | 254 |
| 2025 | 0 | — | 1 | 128 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K963674 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963674: Lumex Air.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963674
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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