510(k) · Cleared
ClearedDevilbiss Model 6305D Heavy Duty AC Aspirator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical Hhg, Inc. · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Jul 17, 1998 as substantially equivalent to K952806 (Thomas Industries, 1995) after a 73-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Jul 17, 1998
- Review
- 73 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952806 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK952806 Medi Pump Aspirator Models 1130 and 1135Thomas Industries · 1995
- This deviceK981602 Devilbiss Model 6305D Heavy Duty AC AspiratorSunrise Medical Hhg, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK260134 Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D…Shenzhen Root Innovation Technology Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A…Shenzhen Root Innovation Technology Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952806 | Medi Pump Aspirator Models 1130 and 1135 | Thomas Industries | 1995 | — |
| 0 (this device) | K981602 | Devilbiss Model 6305D Heavy Duty AC Aspirator | Sunrise Medical Hhg, Inc. | 1998 | — |
| +1 | K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008… | Shenzhen Root Innovation Technology Co., Ltd. | 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 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? (1)
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 |
|---|---|---|---|
| * | K952806 | Medi Pump Aspirator Models 1130 and 1135Summary page 1…ion: Class II Device Equivalent Legally Marketed Predicate Device: Legally Marketed Predicate Devices 510(k) Registration # Thomas Industries Pump Aspirator Model 1135 K952806 Description of Device: : v The DeVilbiss Model 6305D Heavy Duty AC Aspirator is an AC powered vacuum pump assembly designed to b… | 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 |
|---|---|---|---|
| K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A… | 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, K260134 (Shenzhen Root Innovation Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
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 DeVilbiss Model 6305D Heavy Duty AC Aspirator is used primarily to provide
a vacuum source for oral, nasal and pulmonary aspiration. The device is used
on the order of a physician.
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/K981602 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981602: Devilbiss Model 6305D Heavy Duty AC Aspirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981602
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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