PMA · Approved
ApprovedDelta Pacemaker Sys; Vigor DDD Model 950
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Approved on Nov 27, 1985 through premarket approval, which rests on the device’s own clinical evidence after a 341-day review. 7 later devices descend from it.
- Decided
- Nov 27, 1985
- Review
- 341 days
- Class
- Class III
- Product code
- LWP
- Recalls
- None
7 later devices descend from it, 1 citing it directly.
- This deviceP840068 Delta Pacemaker Sys; Vigor DDD Model 950Boston Scientific · 1985
- Descendant · cites it directly · 6 of its ownK962112 New Comfort Contact Lens Care AccessoryLens Comfort, Inc. · 1996
- Descendant · 2 generations on · 4 of its ownK974724 Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic…Lens Comfort, Inc. · 1998
- Descendant · 3 generations on · 3 of its ownK982115 Lenserver Automatic Contact Lens Cleaning AccessoryRim-Wide Companies, Inc. · 1999
- Descendant · 3 generations on · 1 of its ownK021699 Autolens Cleaning and Disinfecting UnitAutolens, Inc. · 2002
- Descendant · 4 generations on · 0 of its ownK211361 3N Contact Lenses Adjunct CleanerSuzhou 3N Biological Technology Co., Ltd. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K962112New Comfort Contact Lens Care AccessoryLens Comfort, Inc. · 1996 · cites it directly6descendants
- K974724Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic Contact Lens Cleaner…Lens Comfort, Inc. · 1998 · 2 generations on4descendants
- K982115Lenserver Automatic Contact Lens Cleaning AccessoryRim-Wide Companies, Inc. · 1999 · 3 generations on3descendants
- K021699Autolens Cleaning and Disinfecting UnitAutolens, Inc. · 2002 · 3 generations on1descendant
- K2113613N Contact Lenses Adjunct CleanerSuzhou 3N Biological Technology Co., Ltd. · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P840068 | Delta Pacemaker Sys; Vigor DDD Model 950 | Boston Scientific | 1985 | — |
| +1 | K962112 | New Comfort Contact Lens Care Accessory | Lens Comfort, Inc. | 1996 | — |
| +2 | K974724 | Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic Contact… | Lens Comfort, Inc. | 1998 | — |
| +3 | K982115 | Lenserver Automatic Contact Lens Cleaning Accessory | Rim-Wide Companies, Inc. | 1999 | — |
| +3 | K021699 | Autolens Cleaning and Disinfecting Unit | Autolens, Inc. | 2002 | — |
| +4 | K211361 | 3N Contact Lenses Adjunct Cleaner | Suzhou 3N Biological Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LWP? 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962112 | New Comfort Contact Lens Care Accessory | 1996 | 6 |
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?
- Of its descendants, K962112 (Lens Comfort, Inc., 1996) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LWP devicesLWP Implantable Pulse Generator, Pacemaker (Non-Crt): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWP
46in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LWP
Too few LWP 510(k)s in any year since 2007 to give a median.
Recalls per year · LWP
21in 2025
Class I (26 since 2007) Class II/III not classified
Adverse event reports per year · LWP
11,931in 2025
MAUDE reports naming product code LWP, 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 | 58 | — | 7 | 49 |
| 2008 | 87 | — | 2 | 496 |
| 2009 | 78 | — | 8 | 805 |
| 2010 | 66 | — | 7 | 678 |
| 2011 | 91 | — | 0 | 684 |
| 2012 | 123 | — | 0 | 1,087 |
| 2013 | 116 | — | 2 | 5,164 |
| 2014 | 126 | — | 2 | 9,400 |
| 2015 | 97 | — | 2 | 9,422 |
| 2016 | 97 | — | 1 | 12,354 |
| 2017 | 116 | — | 21 | 11,643 |
| 2018 | 97 | — | 0 | 14,936 |
| 2019 | 88 | — | 0 | 9,627 |
| 2020 | 90 | — | 0 | 8,989 |
| 2021 | 70 | — | 0 | 9,374 |
| 2022 | 65 | — | 0 | 14,286 |
| 2023 | 54 | — | 0 | 12,633 |
| 2024 | 58 | — | 4 (4) | 10,495 |
| 2025 | 46 | — | 21 (21) | 11,931 |
| 2026 | 40 | — | 1 (1) | — |
https://510kreport.com/device/P840068 · printed Nov 6, 2026
Cite this page
510(k) Report. “P840068: Delta Pacemaker Sys; Vigor DDD Model 950.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P840068
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026