510(k) · Cleared
ClearedScope Guard Protective Sheath, Model Tel-SH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acmi Corporation · OCU Endoscopic Storage Cover
Cleared on Jun 3, 2003 as substantially equivalent to K012105 (Symmetry Medical, Inc., 2002) after a 90-day review. Its family tree reaches back 4 generations to 1984.
- Decided
- Jun 3, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- OCU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K844002 (1984). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 3 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 2 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 1 generation backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- This deviceK030684 Scope Guard Protective Sheath, Model Tel-SHAcmi Corporation · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −3 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −2 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −1 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| 0 (this device) | K030684 | Scope Guard Protective Sheath, Model Tel-SH | Acmi Corporation | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OCU? 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 OCU device
- #1 K202838 Andorate Universal Endoscope Tip Guardscore 1.3 · 2 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K012105 | Polyvac Surgical Instrument Delivery SystemSummary page 4…heath A. Sponsor ACMI CORPORATION . 136 Turnpike Rd Southborough, MA 01772 B. Device Name Scope Guard™ C. Predicate Device Polyvac Surgical Instrument Delivery System (K012105) D. Device Description The Scope Guard Protective Sheath is a polymer tube in various widths and lengths with evenly distributed… | 2002 |
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 19 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- None of the 6 ancestors has a recall.
- 20 other devices also cite its predicate K012105.
How does its category compare?
All OCU devicesOCU Endoscopic Storage Cover: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCU
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · OCU
Too few OCU 510(k)s in any year since 2007 to give a median.
Recalls per year · OCU
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCU
1in 2016
MAUDE reports naming product code OCU, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Scope Guard protective sheath is intended for use during the transport, storage and sterilization of certain ACMI scopes for protection of these delicate instruments. It is not intended to be used alone for terminal sterilization but can be used in conjunction with an approved sterilization wrap to maintain sterility until the device is required for use. The ACMI scopes with Scope Guard can be wrapped, or placed into an approved sterilization tray for sterilization processing.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K030684 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030684: Scope Guard Protective Sheath, Model Tel-SH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030684
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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