510(k) · Cleared
ClearedTasman
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed, Ltd. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Nov 16, 2011 as substantially equivalent to K033841 (Resmed, Ltd., 2004) and 1 other predicate after an 89-day review. Its family tree reaches back 4 generations to 1997. 1 later device descends from it.
- Decided
- Nov 16, 2011
- Review
- 89 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K971260 (1997). 16 ancestors in all, the oldest K930656 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 3 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 2 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 1 generation backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- This deviceK112393 TasmanResmed, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK121705 GEOResmed, Ltd. · 2012
Most influential descendants
Showing 1 of 1 · See all- K121705GEOResmed, Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −3 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −2 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −1 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| 0 (this device) | K112393 | Tasman | Resmed, Ltd. | 2011 | — |
| +1 | K121705 | GEO | Resmed, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 BZD? 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 BZD device
- #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K033841 | Resmed S8 Prime Cpap SystemSummary page 1…Non continuous Ventilator (IPPB) Classification 21 CFR 868.5905 (Class 11) Product Cade 73 BZD Predicate Device S8 Prime (K033841) Ultra Mirage 11Nasal Mask (K050359) Reason for submission New Device Intend… | 2004 |
| * | K050359 | Ultra Mirage II MaskSummary page 1…on 21 CFR 868.5905 (Class 11) Product Cade 73 BZD Predicate Device S8 Prime (K033841) Ultra Mirage 11Nasal Mask (K050359) Reason for submission New Device Intended Use The Tasman is indicated for the treatment of obstructive… | 2005 |
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 |
|---|---|---|---|
| K121705 | GEO | 2012 | 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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K121705 (Resmed, Ltd., 2012) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K033841.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, 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 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
The Tasman is indicated for the treatment of obstructive sleep apnea (OSA) in adult patients weighing more than 66 lb (>30 Kg). The Tasman mask system delivers airflow noninvasively to a user from the integrated Continuous Positive Airway (CPAP) device. The Tasman is intended for single-patient re-use in the home environment and while travelling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112393: Tasman.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112393
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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