510(k) · Cleared
Recalled · Class II · 2013Medisiss Phacoemulsification Tips/Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Instruments Service and Savings, Inc. · NKX Needle, Phacoemulsification, Reprocessed
Cleared on Jan 24, 2003 as substantially equivalent to K981103 (Alcon Laboratories, 1998) and 4 other predicates after a 7-day review. Its family tree reaches back 2 generations to 1990. 4 later devices descend from it. It has been recalled once.
- Decided
- Jan 24, 2003
- Review
- 7 days
- Class
- Class II
- Product code
- NKX
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 2 generations to K902798 (1990). 12 ancestors in all, the oldest K851210 (1985). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK902798 Automated Hydrosonics (TM)Alcon Surgical, Inc. · 1990
- 1 generation backK980292 Cataract Liquefracture DeviceAlcon Laboratories · 1998
- This deviceK030179 Medisiss Phacoemulsification Tips/NeedlesSurgical Instruments Service and Savings, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK041841 PachycamOculus Optikgerate GmbH · 2005
- Descendant · 2 generations on · 1 of its ownK073508 ParkoneOculus Optikgerate GmbH · 2008
- Descendant · 3 generations on · 0 of its ownK202989 Myopia MasterOculus Optikgeräte GmbH · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK113066 Corvis STOculus Optikgerate GmbH · 2012
Most influential descendants
Showing 4 of 4 · See all- K041841PachycamOculus Optikgerate GmbH · 2005 · cites it directly3descendants
- K073508ParkoneOculus Optikgerate GmbH · 2008 · 2 generations on1descendant
- K202989Myopia MasterOculus Optikgeräte GmbH · 2021 · 3 generations on0descendants
- K113066Corvis STOculus Optikgerate GmbH · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902798 | Automated Hydrosonics (TM) | Alcon Surgical, Inc. | 1990 | — |
| −1 | K980292 | Cataract Liquefracture Device | Alcon Laboratories | 1998 | — |
| 0 (this device) | K030179 | Medisiss Phacoemulsification Tips/Needles | Surgical Instruments Service and Savings, Inc. | 2003 | — |
| +1 | K041841 | Pachycam | Oculus Optikgerate GmbH | 2005 | — |
| +2 | K073508 | Parkone | Oculus Optikgerate GmbH | 2008 | — |
| +3 | K202989 | Myopia Master | Oculus Optikgeräte GmbH | 2021 | 1 |
| +2 | K113066 | Corvis ST | Oculus Optikgerate GmbH | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2021 | 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 NKX? 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? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981103 | Turbosonics Limited Reuse Ultrasonic TipSummary page 5…as listed below: Company 510(k) # 1 *icon K98 1103, K861380, K832836, K902798, K911808. K980292 They ar… | 1998 |
| * | K861380 | Series Ten Thousand MasterSummary page 5…below: Company 510(k) # 1 *icon K98 1103, K861380, K832836, K902798, K911808. K980292 They are also si… | 1986 |
| Kept off the family tree | K832836 | FDA’s K832836 is Basal Med. #B9763 W/Hanks Salts W/L-G Our reading of the summary gave K832836, FDA’s number for Basal Med. #B9763 W/Hanks Salts W/L-G (Sigma Chemical Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “ALCON Phacoemulsification Tips/Needles”. Kept off the family tree. Summary page 5…Company 510(k) # 1 *icon K98 1103, K861380, K832836, K902798, K911808. K980292 They are also similar to… | 1983 |
| * | K902798 | Automated Hydrosonics (TM)Summary page 5…Company 510(k) # 1 *icon K98 1103, K861380, K832836, K902798, K911808. K980292 They are also similar to the repro… | 1990 |
| * | K911808 | Gemini Ophthalmic Surgery SystemSummary page 5…1 *icon K98 1103, K861380, K832836, K902798, K911808. K980292 They are also similar to the reprocessed hot biopsy forceps reprocessed by Alliance Cor-… | 1991 |
| * | K980292 | Cataract Liquefracture DeviceSummary page 5…con K98 1103, K861380, K832836, K902798, K911808. K980292 They are also similar to the reprocessed hot biopsy forceps reprocessed by Alliance Cor- poration… | 1998 |
| † | K012637 | Alliance Corporation reprocessed hot biopsy forceps | |
| † | K012579 | Reprocessed Phaco Tips | 2001 |
| † | K012609 | Clearmedical/Nellcor Oxisensor II, Neonatal/Adult, Model N-25 | 2002 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041841 | Pachycam | 2005 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 3, 2013 | Class II | Z-1642-2013 | Packaging process control | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K041841 (Oculus Optikgerate GmbH, 2005) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K981103.
How does its category compare?
All NKX devicesNKX Needle, Phacoemulsification, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NKX
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · NKX
Too few NKX 510(k)s in any year since 2007 to give a median.
Recalls per year · NKX
10in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKX
3in 2010
MAUDE reports naming product code NKX, 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 | — | 0 | 2 |
| 2008 | 0 | — | 10 | 3 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MediSISS™ Reprocessed Phacoemulsification Tips/Needles are intended to emulsify
and excise cataract tissue in ophthalmic microsurgical procedures.
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/K030179 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030179: Medisiss Phacoemulsification Tips/Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030179
Report an extraction error
Are you the manufacturer?
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