510(k) · Cleared
ClearedMedela Clario Home Care Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medela AG · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Oct 15, 2003 as substantially equivalent to K983552 (Medela, Inc., 1999) and 3 other predicates after a 14-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Oct 15, 2003
- Review
- 14 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K862569 (1986). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK862569 Heavy Duty (HD) Suction Units (W/Cannulas)Jedmed Instrument Co. · 1986
- This deviceK033179 Medela Clario Home Care PumpMedela AG · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862569 | Heavy Duty (HD) Suction Units (W/Cannulas) | Jedmed Instrument Co. | 1986 | — |
| 0 (this device) | K033179 | Medela Clario Home Care Pump | Medela AG | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1999 | 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 BTA? 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 BTA device
- #1 K222547 Electric nasal aspiratorscore 20.7 · 6 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 |
|---|---|---|---|
| * | K983552 | Basic, Median, Dominant, and VarioSummary page 1…(Classified Class II, per 21 CFR Section 878.4780). 3 Name of the legally marketed Device(s): MedelaGD Vario Suction Pumps, by Medela Inc., K983552 Heavy Duty (HD) Suction Units (Atmos LC 16) by Jedmed Instrument Co, K862569 605 VACU-MAX, by Medical Industries America, Inc., K… | 1999 |
| * | K862569 | Heavy Duty (HD) Suction Units (W/Cannulas)Summary page 1…Name of the legally marketed Device(s): MedelaGD Vario Suction Pumps, by Medela Inc., K983552 Heavy Duty (HD) Suction Units (Atmos LC 16) by Jedmed Instrument Co, K862569 605 VACU-MAX, by Medical Industries America, Inc., K941961 Power Pack Suction, Ambu International N S , K932031 G-51OSummary.… | 1986 |
| * | K941961 | 605 Vacu-MaxSummary page 1…io Suction Pumps, by Medela Inc., K983552 Heavy Duty (HD) Suction Units (Atmos LC 16) by Jedmed Instrument Co, K862569 605 VACU-MAX, by Medical Industries America, Inc., K941961 Power Pack Suction, Ambu International N S , K932031 G-51OSummary.doc 2003-06-16… | 1995 |
| * | K932031 | Ambu Portable Suction UnitSummary page 1…(HD) Suction Units (Atmos LC 16) by Jedmed Instrument Co, K862569 605 VACU-MAX, by Medical Industries America, Inc., K941961 Power Pack Suction, Ambu International N S , K932031 G-51OSummary.doc 2003-06-16 Section G, Page 1 Applicant:… | 1995 |
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 4 ancestors has a recall.
- 8 other devices also cite its predicate K983552.
How does its category compare?
All BTA devicesBTA Pump, Portable, Aspiration (Manual Or Powered): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTA
7so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · BTA
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTA
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BTA
13in 2025
MAUDE reports naming product code BTA, 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 | 1 | — | 1 | 13 |
| 2008 | 3 | 135 | 3 | 5 |
| 2009 | 2 | — | 0 | 14 |
| 2010 | 2 | — | 3 | 178 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 3 | 45 | 0 | 18 |
| 2014 | 3 | 91 | 0 | 399 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 3 | 149 | 0 | 25 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 4 | 125 | 0 | 17 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 1 | — | 0 | 10 |
| 2021 | 1 | — | 1 | 9 |
| 2022 | 3 | 58 | 0 | 7 |
| 2023 | 4 | 265 | 0 | 8 |
| 2024 | 5 | 131 | 0 | 13 |
| 2025 | 6 | 87 | 0 | 13 |
| 2026 | 7 | 89 | 0 | — |
What is it indicated for?
The Medela CLARIO Suction Pumps are indicated for aspiration and removal of secretions, bodily fluids and foreign objects from a patient's airway or respiratory support system in the nasal, pharyngeal and tracheal areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033179 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033179: Medela Clario Home Care Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033179
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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