510(k) · Cleared
ClearedI/a (Irrigation/Aspiration) Pack, Posterior Vitrecomy Pack, Anterior Virectomy Pack, Phacoemulsification Pack, Admiinisn
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ophthalmic Consultants, Inc. · HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Cleared on Nov 19, 1999 as substantially equivalent to K980100 (Storz Instrument Co., 1998) and 6 other predicates after a 294-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Nov 19, 1999
- Review
- 294 days
- Class
- Class II
- Product code
- HQE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K882240 (1988). 12 ancestors in all, the oldest K832761 (1983). No later device cites it as a predicate yet.
- Root · 3 generations backK882240 Storz Univ Irrigat/Aspira & Phacoemulsifcation PacStorz Instrument Co. · 1988
- 2 generations backK955901 Storz DP4310DELUXE Phaco Pack Without RefluxStorz Instrument Co. · 1996
- 1 generation backK961831 Storz DP5200 Irrigation Addministration Set PackStorz Instrument Co. · 1996
- This deviceK990292 I/a (Irrigation/Aspiration) Pack, Posterior Vitrecomy Pack, Anterior…Ophthalmic Consultants, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K882240 | Storz Univ Irrigat/Aspira & Phacoemulsifcation Pac | Storz Instrument Co. | 1988 | — |
| −2 | K955901 | Storz DP4310DELUXE Phaco Pack Without Reflux | Storz Instrument Co. | 1996 | — |
| −1 | K961831 | Storz DP5200 Irrigation Addministration Set Pack | Storz Instrument Co. | 1996 | — |
| 0 (this device) | K990292 | I/a (Irrigation/Aspiration) Pack, Posterior Vitrecomy Pack, Anterior Virectomy… | Ophthalmic Consultants, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 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 HQE? 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 HQE device
- #1 K212763 UniVit HE, UniVit UHSscore 4.1 · 2 generations · no Class I recall
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K980100 | Storz DP4210 Venturi Economy Anterior Pack and DP5000 Asc DaypackSummary page 2…ass: Class II Performance Standards: No performance standards have been officially adopted by the FDA. Predicate Devices: The above packs are substantially equivalent to K980100, K962131,K961874, K961831, K955901, K953575, and K913504, et al, all of which were determined to be SE. Description: Ophthalmic… | 1998 |
| * | K962131 | Storz D4600 Air Exchange Line PackSummary page 2…II Performance Standards: No performance standards have been officially adopted by the FDA. Predicate Devices: The above packs are substantially equivalent to K980100, K962131,K961874, K961831, K955901, K953575, and K913504, et al, all of which were determined to be SE. Description: Ophthalmic surgical k… | 1996 |
| * | K961874 | Storz DP5100 Anterior Collection Cassette PackSummary page 2…ormance Standards: No performance standards have been officially adopted by the FDA. Predicate Devices: The above packs are substantially equivalent to K980100, K962131,K961874, K961831, K955901, K953575, and K913504, et al, all of which were determined to be SE. Description: Ophthalmic surgical kits/pack… | 1996 |
| * | K961831 | Storz DP5200 Irrigation Addministration Set PackSummary page 2…tandards: No performance standards have been officially adopted by the FDA. Predicate Devices: The above packs are substantially equivalent to K980100, K962131,K961874, K961831, K955901, K953575, and K913504, et al, all of which were determined to be SE. Description: Ophthalmic surgical kits/packs contain… | 1996 |
| * | K955901 | Storz DP4310DELUXE Phaco Pack Without RefluxSummary page 2…No performance standards have been officially adopted by the FDA. Predicate Devices: The above packs are substantially equivalent to K980100, K962131,K961874, K961831, K955901, K953575, and K913504, et al, all of which were determined to be SE. Description: Ophthalmic surgical kits/packs containing compo… | 1996 |
| * | K953575 | Storz MVS-3201 Vitrectomy Probe PackSummary page 2…rmance standards have been officially adopted by the FDA. Predicate Devices: The above packs are substantially equivalent to K980100, K962131,K961874, K961831, K955901, K953575, and K913504, et al, all of which were determined to be SE. Description: Ophthalmic surgical kits/packs containing components use… | 1995 |
| * | K913504 | Storz Micro Cutter 25 Gauge PackSummary page 2…rds have been officially adopted by the FDA. Predicate Devices: The above packs are substantially equivalent to K980100, K962131,K961874, K961831, K955901, K953575, and K913504, et al, all of which were determined to be SE. Description: Ophthalmic surgical kits/packs containing components used for irrigat… | 1992 |
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 11 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 12 ancestors has a recall.
How does its category compare?
All HQE devicesHQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQE
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HQE
Too few HQE 510(k)s in any year since 2007 to give a median.
Recalls per year · HQE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQE
339in 2025
MAUDE reports naming product code HQE, 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 | — | 2 | 300 |
| 2008 | 0 | — | 0 | 65 |
| 2009 | 0 | — | 0 | 34 |
| 2010 | 0 | — | 11 | 27 |
| 2011 | 1 | — | 0 | 21 |
| 2012 | 2 | — | 0 | 34 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 1 | — | 4 | 10 |
| 2017 | 1 | — | 0 | 59 |
| 2018 | 0 | — | 0 | 309 |
| 2019 | 0 | — | 0 | 41 |
| 2020 | 0 | — | 0 | 30 |
| 2021 | 0 | — | 0 | 32 |
| 2022 | 1 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 108 |
| 2024 | 0 | — | 0 | 105 |
| 2025 | 0 | — | 1 | 339 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
To provide single-use components to be used in conjunction with a facility’s existing compatable equipment, in one convenient kit/pack, for ophthalmic surgical procedures, used in accordance with the equipment manufacturer’s instructions, performed by a certified clinician in a clinical setting, as follows: 01. Phaco Emulsifier Pack: Provides the irrigation and aspiration tubing/ administration sets and equipment covers/drapes used in anterior, e.g.…
Read the full statement (208 words)
To provide single-use components to be used in conjunction with a facility’s existing
compatable equipment, in one convenient kit/pack, for ophthalmic surgical procedures, used
in accordance with the equipment manufacturer’s instructions, performed by a certified
clinician in a clinical setting, as follows:
01. Phaco Emulsifier Pack: Provides the irrigation and aspiration tubing/
administration sets and equipment covers/drapes used in anterior, e.g., cataract,
surgical procedures;
02. Anterior Vitrectomy Pack: Provides the vitrector, surgical blade, scleral plugs
for incision patency, and 10 cc syringe and fluid irrigation and aspiration
tubing/administration sets, and equipment covers/drapes, used in anterior
surgical procedures;
03. Anterior Collection Cassette: Provides the fluid collection cassette and
tubing for the collection and disposal of fluids during ophthalmic anterior
surgical procedures;
04. Posterior Vitrectomy Pack: Provides the vitrector, surgical blade, scleral plugs
for incision patency, and 10 cc syringe and fluid irrigation and aspiration
tubing/administration sets, and equipment covers/drapes, used in posterior
segment, e.g., retinal, surgical procedures;
05. Posterior Collection Cassette: Provides the fluid collection cassette and
tubing for the collection and disposal of fluids during ophthalmic posterior
surgical procedures.
06. Filtered Irrigation Administration Set: Provides commonly used tubing sets
for the filtering and administration of fluids for flushing/irrigating a surgical
site during either posterior or anterior ophthalmic 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/K990292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990292: I/a (Irrigation/Aspiration) Pack, Posterior Vitrecomy Pack, Anterior Virectomy Pack, Phacoemulsification Pack, Admiinisn.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990292
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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