510(k) · Cleared
ClearedMercury Medical CPR Bag Exhalation Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mercury Medical · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Oct 3, 1996 as substantially equivalent to K851070 (Medicomp, Inc., 1985) after a 372-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.
- Decided
- Oct 3, 1996
- Review
- 372 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K851070 (1985). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K251583Ambu® Virobac II® Exhalation FilterAmbu A/S · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851070 | Resp-Bac Bacteria Filter | Medicomp, Inc. | 1985 | — |
| 0 (this device) | K954490 | Mercury Medical CPR Bag Exhalation Filter | Mercury Medical | 1996 | — |
| +1 | K251583 | Ambu® Virobac II® Exhalation Filter | Ambu A/S | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 CAH? 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 CAH device
- #1 K251583 Ambu® Virobac II® Exhalation Filterscore 11.6 · 2 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K911622 | FDA’s K911622 is CPR Bag Our OCR of the scanned summary read K911622, FDA’s number for CPR Bag (Merced Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Mercury Medical CPR Resuscitator”. Kept off the family tree. Summary page 1…uirements of the Safe Medical Devices Act 1990 and 21 CFR 897.92. This device is the combination of two previously cleared devices: the Mercury Medical CPR Resuscitator (K911622) with Filter manufactured by Medicomp (K851070), which has been subsequently tested and supported with independent laboratory dat… | 1991 |
| * | K851070 | Resp-Bac Bacteria FilterSummary page 1…and 21 CFR 897.92. This device is the combination of two previously cleared devices: the Mercury Medical CPR Resuscitator (K911622) with Filter manufactured by Medicomp (K851070), which has been subsequently tested and supported with independent laboratory data for BFE and VFE. This would be consistent wi… | 1985 |
| † | K883693 | Resuscitation Bag Exhalation Filter | 1988 |
| † | K951484 | Westmed Bacterial/Viral Filter | 1995 |
| † | K953687 | Westmed Pediatric Bacterial/Viral Filter | 1995 |
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 |
|---|---|---|---|
| K251583 | Ambu® Virobac II® Exhalation Filter | 2026 | 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?
- Its one ancestor has no recall.
- Of its descendants, K251583 (Ambu A/S, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAH
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CAH
237in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAH
1in 2025
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · CAH
77in 2025
MAUDE reports naming product code CAH, 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 | 2 | — | 0 | 32 |
| 2008 | 1 | — | 0 | 27 |
| 2009 | 4 | 111 | 0 | 18 |
| 2010 | 5 | 216 | 2 | 40 |
| 2011 | 3 | 281 | 0 | 9 |
| 2012 | 3 | 212 | 0 | 16 |
| 2013 | 1 | — | 1 | 47 |
| 2014 | 4 | 250 | 1 | 98 |
| 2015 | 2 | — | 0 | 51 |
| 2016 | 0 | — | 0 | 34 |
| 2017 | 1 | — | 1 | 29 |
| 2018 | 0 | — | 0 | 33 |
| 2019 | 2 | — | 0 | 30 |
| 2020 | 2 | — | 0 | 33 |
| 2021 | 2 | — | 0 | 56 |
| 2022 | 3 | 204 | 6 (6) | 67 |
| 2023 | 3 | 237 | 0 | 40 |
| 2024 | 2 | — | 0 | 51 |
| 2025 | 0 | — | 1 (1) | 77 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K954490 · printed Nov 5, 2026
Cite this page
510(k) Report. “K954490: Mercury Medical CPR Bag Exhalation Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954490
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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