510(k) · Cleared
ClearedAnodyne CC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heyer America, Inc. · BSZ Gas-Machine, Anesthesia
Cleared on Aug 11, 1997 as substantially equivalent to K882489 (Ohmeda Medical, 1988) and 1 other predicate after a 342-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Aug 11, 1997
- Review
- 342 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K882489 (1988). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK882489 Revised Pneumatic Diagrams for Modulus II PlusOhmeda Medical · 1988
- This deviceK963481 Anodyne CCHeyer America, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882489 | Revised Pneumatic Diagrams for Modulus II Plus | Ohmeda Medical | 1988 | — |
| 0 (this device) | K963481 | Anodyne CC | Heyer America, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 |
|---|---|---|---|
| * | K882489 | Revised Pneumatic Diagrams for Modulus II Plus Our OCR of the scanned summary read K882484, FDA’s number for CMS Record and Verify System (Computerized Medical Systems, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Modulus II Plus Ohmeda”. | 1988 |
| * | K930351 | Narkomed 2C Anesthesia SystemSummary page 1…Phone: 813-942-3908 Fax 813-942-3828 Ed Ransom August Heyer America® Anodyne™ CC Gas Machine for Anesthesia, 21CFR section 868.5160 K882484 Modulus Il Plus Ohmeda K930351 Narkomed 2C North American Drager The HEYER America® Anodyne™ CC Anesthesia System is a standalone anesthesia device. The device… | 1993 |
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.
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 AnodyneTM CC-Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient’s ventilation.
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/K963481 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963481: Anodyne CC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963481
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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