510(k) · Cleared
Recalled · Class II · 2012California Medical Laboratories Inc. Standard and Small Rigid Tip Suction Wands
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
California Medical Laboratories, Inc. · DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Cleared on Sep 30, 1998 after a 44-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 10 times.
- Decided
- Sep 30, 1998
- Review
- 44 days
- Class
- Class II
- Product code
- DTS
- Recalls
- 10
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK982891 California Medical Laboratories Inc. Standard and Small Rigid Tip…California Medical Laboratories, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK053021 Estech Clearview MV Atrial DepressorEstech, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K053021Estech Clearview MV Atrial DepressorEstech, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982891 | California Medical Laboratories Inc. Standard and Small Rigid Tip Suction Wands | California Medical Laboratories, Inc. | 1998 | — |
| +1 | K053021 | Estech Clearview MV Atrial Depressor | Estech, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 DTS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Research Medical, Inc. Rigid Intracardiac Suction Wand Named without a submission number |
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 |
|---|---|---|---|
| K053021 | Estech Clearview MV Atrial Depressor | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 2, 2012 | Class II | Z-0649-2013 | Nonconforming Material/Component | California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity. |
| Nov 2, 2012 | Class II | Z-0650-2013 | Nonconforming Material/Component | California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity. |
| Feb 5, 2008 | Not classified | Z-2046-2009 | Process control | A loose strand of stainless steel left on the device during manufacturing may result in an unretrieved metal fragment remaining in the patient. |
| Jan 29, 2008 | Not classified | Z-1311-2008 | Nonconforming Material/Component | Loose Flash at tip of Weighted Flexible Sucker: A loose strand of stainless steel left on the device during manufacturing by an outside supplier may result in an unretrieved metal fragment remaining in the patient. |
| Jan 29, 2008 | Not classified | Z-1312-2008 | Nonconforming Material/Component | Loose Flash at tip of Weighted Flexible Sucker: A loose strand of stainless steel left on the device during manufacturing by an outside supplier may result in an unretrieved metal fragment remaining in the patient. |
| Jan 29, 2008 | Not classified | Z-1310-2008 | Nonconforming Material/Component | Loose Flash at tip of Weighted Flexible Sucker: A loose strand of stainless steel left on the device during manufacturing by an outside supplier may result in an unretrieved metal fragment remaining in the patient. |
| Jan 29, 2008 | Not classified | Z-1313-2008 | Nonconforming Material/Component | Loose Flash at tip of Weighted Flexible Sucker: A loose strand of stainless steel left on the device during manufacturing by an outside supplier may result in an unretrieved metal fragment remaining in the patient. |
| Jan 24, 2008 | Not classified | Z-1175-2008 | Process control | Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product. |
| Jan 24, 2008 | Not classified | Z-1176-2008 | Process control | Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product. |
| Jan 24, 2008 | Not classified | Z-1177-2008 | Process control | Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K053021 (Estech, Inc., 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DTS devicesDTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTS
FDA has decided no DTS device since 2007.
Median 510(k) review, days · DTS
Too few DTS 510(k)s in any year since 2007 to give a median.
Recalls per year · DTS
2in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTS
17in 2025
MAUDE reports naming product code DTS, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 4 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 3 | 4 |
| 2012 | 0 | — | 2 | 8 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 107 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 17 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Standard and Small Rigid Tip Suction Wands are indicated for use to remove excess fluid from the surgical field.
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/K982891 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982891: California Medical Laboratories Inc. Standard and Small Rigid Tip Suction Wands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982891
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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