510(k) · Cleared
ClearedSaphlift
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genzyme Surgical Product (Genzyme Biosurgery) · MDM Instrument, Manual, Surgical, General Use
Cleared on Mar 30, 1999 as substantially equivalent to K951854 (Leonard Medical, Inc., 1995) and 1 other predicate after an 81-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Mar 30, 1999
- Review
- 81 days
- Class
- Class I
- Product code
- MDM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K951854 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 MDM? 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? (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 |
|---|---|---|---|
| * | K951854 | Leonard Arm - Support Arm - Endoscopic AccessorySummary page 1…DEVICE NAME Proprietary Name: SAPHLIFT Common/Usual Name: Surgical instrument holder Classification Name: Manual Surgical Instrument 3. PREDICATE DEVICES Leonard Arms (K951854) Kronner Low Profile Scope Holder (K973543) 4. INTENDED USE The SAPHLIFT is a holding and manipulating arm for use in surgery w… | 1995 |
| * | K973543 | Kronner Low Profile Scope HolderSummary page 1…on/Usual Name: Surgical instrument holder Classification Name: Manual Surgical Instrument 3. PREDICATE DEVICES Leonard Arms (K951854) Kronner Low Profile Scope Holder (K973543) 4. INTENDED USE The SAPHLIFT is a holding and manipulating arm for use in surgery which allows the operating team to hold surg… | 1998 |
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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K951854.
How does its category compare?
All MDM devicesMDM Instrument, Manual, Surgical, General Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MDM
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · MDM
Too few MDM 510(k)s in any year since 2007 to give a median.
Recalls per year · MDM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MDM
318in 2025
MAUDE reports naming product code MDM, 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 | 25 |
| 2008 | 1 | — | 0 | 50 |
| 2009 | 0 | — | 1 | 131 |
| 2010 | 0 | — | 17 | 49 |
| 2011 | 0 | — | 1 | 52 |
| 2012 | 0 | — | 0 | 53 |
| 2013 | 0 | — | 0 | 74 |
| 2014 | 0 | — | 1 | 66 |
| 2015 | 0 | — | 0 | 161 |
| 2016 | 0 | — | 0 | 317 |
| 2017 | 0 | — | 2 | 187 |
| 2018 | 0 | — | 0 | 400 |
| 2019 | 0 | — | 0 | 281 |
| 2020 | 0 | — | 0 | 245 |
| 2021 | 0 | — | 1 | 227 |
| 2022 | 0 | — | 2 | 182 |
| 2023 | 0 | — | 0 | 209 |
| 2024 | 0 | — | 1 | 507 |
| 2025 | 0 | — | 0 | 318 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The SAPHLIFT is a holding and manipulating arm for use in surgery which allows the operating team to hold manual surgical instruments and the SaphLite Retractor in a given position and to change that position immediately with one hand.
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/K990062 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990062: Saphlift.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990062
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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