510(k) · Cleared
ClearedMADM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thornhill Research, Inc. · BSZ Gas-Machine, Anesthesia
Cleared on Jan 5, 2015 as substantially equivalent to K850648 (Ohmeda Medical, 1985) and 3 other predicates after a 336-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Jan 5, 2015
- Review
- 336 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K935370 (1994). 13 ancestors in all, the oldest K850648 (1985). No later device cites it as a predicate yet.
- Root · 5 generations backK935370 Miniox IA Oxygen AnalyzerMinesafety Appliances Co. · 1994
- 4 generations backK973282 Handi Oxygen AnalyzerCeramatec, Inc. · 1998
- 3 generations backK051857 Veo Multigas Monitor for Pocket PC, Model 400221Weissburg Associates · 2005
- 2 generations backK081601 Veo Multigas Monitor for Pocket PCPhasein AB · 2008
- 1 generation backK123043 Irma C02 Model 200101; Irma AX 200601Phasein AB · 2012
- This deviceK140264 MADMThornhill Research, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935370 | Miniox IA Oxygen Analyzer | Minesafety Appliances Co. | 1994 | — |
| −4 | K973282 | Handi Oxygen Analyzer | Ceramatec, Inc. | 1998 | — |
| −3 | K051857 | Veo Multigas Monitor for Pocket PC, Model 400221 | Weissburg Associates | 2005 | — |
| −2 | K081601 | Veo Multigas Monitor for Pocket PC | Phasein AB | 2008 | — |
| −1 | K123043 | Irma C02 Model 200101; Irma AX 200601 | Phasein AB | 2012 | — |
| 0 (this device) | K140264 | MADM | Thornhill Research, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 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 BSZ? 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 BSZ device
- #1 K253330 A5 Anesthesia System (A5); A7 Anesthesia…score 16.7 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K850648 | Ohmeda Pac Portable Anesthesia SystemSummary page 5…evices: Device 510(k) # PAC Vaporizer K850648 Penlon Sigma Delta Vaporizer K002343 Tec-6 Plus Vaporizer… | 1985 |
| * | K002343 | Sigma DeltaSummary page 5…510(k) # PAC Vaporizer K850648 Penlon Sigma Delta Vaporizer K002343 Tec-6 Plus Vaporizer K000275 IRMA… | 2001 |
| * | K000275 | Datex-Ohmeda Tec 6 Plus Anesthesia Vaporizer, Datex-Ohmeda Tec 6 Plus Nad Variant…Summary page 5…K850648 Penlon Sigma Delta Vaporizer K002343 Tec-6 Plus Vaporizer K000275 IRMA K123043 Comparison to Predicate Device MADM™ and the… | 2000 |
| * | K123043 | Irma C02 Model 200101; Irma AX 200601Summary page 5…K002343 Tec-6 Plus Vaporizer K000275 IRMA K123043 Comparison to Predicate Device MADM™ and the predicate devices have the same intended use. Namely, each device is intended for t… | 2012 |
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?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 4 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K850648.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · BSZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSZ
145in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSZ
5in 2025
Class I (38 since 2007) Class II/III not classified
Adverse event reports per year · BSZ
9,198in 2025
MAUDE reports naming product code BSZ, 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 | 3 | 175 | 1 | 132 |
| 2008 | 8 | 99 | 8 | 104 |
| 2009 | 3 | 34 | 3 | 85 |
| 2010 | 1 | — | 14 | 97 |
| 2011 | 6 | 218 | 1 | 87 |
| 2012 | 5 | 134 | 7 (6) | 89 |
| 2013 | 5 | 125 | 5 (5) | 308 |
| 2014 | 4 | 235 | 0 | 279 |
| 2015 | 4 | 134 | 7 (2) | 572 |
| 2016 | 1 | — | 1 | 2,135 |
| 2017 | 3 | 145 | 5 (1) | 2,355 |
| 2018 | 2 | — | 3 | 2,589 |
| 2019 | 0 | — | 5 (2) | 1,957 |
| 2020 | 1 | — | 7 | 2,687 |
| 2021 | 1 | — | 2 (1) | 3,123 |
| 2022 | 0 | — | 4 (3) | 4,352 |
| 2023 | 2 | — | 6 | 5,595 |
| 2024 | 0 | — | 13 (13) | 6,067 |
| 2025 | 1 | — | 5 (3) | 9,198 |
| 2026 | 2 | — | 7 (2) | — |
What is it indicated for?
MADM™ is intended to deliver volatile anesthetic to a patient when placed in either circle or open anesthetic circuits. It vaporizes Isoflurane and Sevoflurane and delivers the vaporized anesthetic agent into the inspiratory limb of the breathing circuit.
MADM™ is also intended to monitor respiratory rate, CO2, and the anesthetic gases Isoflurane and Sevoflurane. It is intended to be connected to a patient breathing circuit for monitoring of patients to whom it is delivering volatile anesthetic gases.
The intended patient population is adults who weigh more than 40 kg.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140264: MADM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140264
Report an extraction error
Are you the manufacturer?
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