510(k) · Cleared
ClearedMastel Laser Clean Room, Model Ebs-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mastel Precision Surgical Instruments, Inc. · FYD Apparatus, Exhaust, Surgical
Cleared on Oct 4, 2005 as substantially equivalent to K011462 (Conception Technologies, 2001) and 2 other predicates after a 291-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Oct 4, 2005
- Review
- 291 days
- Class
- Class II
- Product code
- FYD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K011462 (2001). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK011462 Oil for Tissue CultureConception Technologies · 2001
- This deviceK043494 Mastel Laser Clean Room, Model Ebs-100Mastel Precision Surgical Instruments, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011462 | Oil for Tissue Culture | Conception Technologies | 2001 | — |
| 0 (this device) | K043494 | Mastel Laser Clean Room, Model Ebs-100 | Mastel Precision Surgical Instruments, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 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 FYD? 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 FYD device
- #1 K240127 PlumeSafe X5 Smoke Management Systemscore 8.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011462 | Oil for Tissue CultureSummary page 2…vices to which we are claiming equivalence [807.92(a)(3)]: Device Ref# Decided OIL FOR TISSUE CULTURE K011462 06/13/2001 ENHANCE-S PLUS H K030116 02/12/2003 ENHANCE SPERM FREEZE… | 2001 |
| * | K030116 | Enhance-S Plus HSummary page 2…Ref# Decided OIL FOR TISSUE CULTURE K011462 06/13/2001 ENHANCE-S PLUS H K030116 02/12/2003 ENHANCE SPERM FREEZE K030117 03/20/2003 Description of the devices:… | 2003 |
| * | K030117 | Enhance Sperm FreezeSummary page 2…LTURE K011462 06/13/2001 ENHANCE-S PLUS H K030116 02/12/2003 ENHANCE SPERM FREEZE K030117 03/20/2003 Description of the devices: Oil For Tissue Culture is a colorless liquid paraffin.… | 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?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K011462.
How does its category compare?
All FYD devicesFYD Apparatus, Exhaust, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FYD
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FYD
71in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FYD
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FYD
15in 2025
MAUDE reports naming product code FYD, 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 | 3 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 1 | 39 |
| 2011 | 0 | — | 0 | 150 |
| 2012 | 0 | — | 0 | 120 |
| 2013 | 0 | — | 0 | 142 |
| 2014 | 1 | — | 0 | 71 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 3 | 71 | 0 | 11 |
| 2020 | 1 | — | 0 | 11 |
| 2021 | 1 | — | 0 | 20 |
| 2022 | 1 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 2 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 15 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
Oil For Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.
Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.
SpermFreeze is intended to be used as a cryopreservation medium for human sperm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043494: Mastel Laser Clean Room, Model Ebs-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043494
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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