510(k) · Cleared
Recalled · 2011Prima Anaesthesia Machine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Penlon, Ltd. · BSZ Gas-Machine, Anesthesia
Cleared on Jul 28, 2006 as substantially equivalent to K844008 (Penlon, Inc., 1985) and 1 other predicate after a 100-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 28, 2006
- Review
- 100 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K844008 (1985). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K132903Dre VenturaDre Medical, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K844008 | Penlon AM1000 Anaesthesia Machine | Penlon, Inc. | 1985 | — |
| 0 (this device) | K061102 | Prima Anaesthesia Machine | Penlon, Ltd. | 2006 | — |
| +1 | K132903 | Dre Ventura | Dre Medical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (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 |
|---|---|---|---|
| * | K844008 | Penlon AM1000 Anaesthesia MachineSummary page 1…FR 868.5160 7. Legally marketed predicate devices to which substantial equivalence is claimed: 1. Penlon Limited AM1000 Anaesthesia Machine - FDA 510(k) No. K844008 Approval to market this device given by FDA on March 12, 1985 FDA Device Classification: Class 2 FDA Regu… | 1985 |
| * | K864590 | AM1000Summary page 1…FDA Regulation Number: 21CFR 868.5160 FDA Classification Code: BSZ 2. Bear Medical Systems, Inc. AM1000 Anaesthesia Machine - FDA 510(k) No. K864590 Approval to market this device given by FDA on May 4, 1987 FDA Device Classification: Class 2 FDA Regulat… | 1987 |
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 |
|---|---|---|---|
| K132903 | Dre Ventura | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 29, 2011 | Not classified | Z-1318-2012 | Component design/selection | Penlon, Ltd has identified the potential for the premature failure of a component in some Electronic Flowmeter sensor display unit PCB assemblies. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K132903 (Dre Medical, Inc., 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Penlon Prima Anaesthesia Machine is designed to deliver a combination of medical gases and volatile anaesthetic agents to a breathing system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K061102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061102: Prima Anaesthesia Machine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061102
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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