510(k) · Cleared
ClearedCygnus Instrument Protectors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Madison Polymeric Engineering · FRG Wrap, Sterilization
Cleared on May 6, 1997 as substantially equivalent to K771123 (Devon Industries, Inc., 1977) after a 193-day review. Its family tree reaches back 1 generation to 1977.
- Decided
- May 6, 1997
- Review
- 193 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K771123 (1977). No later device cites it as a predicate yet.
- Root · 1 generation backK771123 Surgical Instrument ProtectorDevon Industries, Inc. · 1977
- This deviceK964256 Cygnus Instrument ProtectorsMadison Polymeric Engineering · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K771123 | Surgical Instrument Protector | Devon Industries, Inc. | 1977 | — |
| 0 (this device) | K964256 | Cygnus Instrument Protectors | Madison Polymeric Engineering | 1997 | — |
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 FRG? 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 FRG device
- #1 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K771123 | Surgical Instrument ProtectorSummary page 1…, 14569 Titus Street, Panorama City, California 91402 9530 Desoto Drive, Chatsworth, California 91311 Product - Devon Tiprotectors, tray pads and liners 510(k) Number - K771123 General and Plastic Surgery Device Panel Classification - Class II Regulatory Citation - 21 CFR ch 1 (4-1-95) Product Descript… | 1977 |
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?
- Its one ancestor has no recall.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRG
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRG
151in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRG
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRG
18in 2025
MAUDE reports naming product code FRG, 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 | 3 | 182 | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 4 | 171 | 0 | 2 |
| 2010 | 4 | 213 | 0 | 0 |
| 2011 | 6 | 110 | 0 | 12 |
| 2012 | 10 | 133 | 0 | 4 |
| 2013 | 6 | 146 | 2 | 5 |
| 2014 | 8 | 177 | 0 | 13 |
| 2015 | 12 | 196 | 0 | 9 |
| 2016 | 9 | 131 | 0 | 20 |
| 2017 | 9 | 260 | 29 | 7 |
| 2018 | 5 | 150 | 0 | 22 |
| 2019 | 9 | 258 | 0 | 10 |
| 2020 | 5 | 122 | 14 | 21 |
| 2021 | 4 | 170 | 0 | 9 |
| 2022 | 9 | 217 | 2 | 4 |
| 2023 | 9 | 230 | 0 | 13 |
| 2024 | 11 | 182 | 0 | 21 |
| 2025 | 9 | 151 | 0 | 18 |
| 2026 | 4 | 247 | 0 | — |
What is it indicated for?
The primary purpose of the device is to protect surgicsl instruments during sterilization, storage and transportation to the surgical suite. This product is intended to be used by hospital staff during the preparation of the sterile instrument kits. The linets are first placed into the empty sterilization tray. The instruments are then placed onto the Cygnus liner (or in the pouch) and the trays arc wrapped in CSR wrsp using conventional wrapping…
Read the full statement (132 words)
The primary purpose of the device is to protect surgicsl instruments during sterilization, storage and transportation to the surgical suite. This product is intended to be used by hospital staff during the preparation of the sterile instrument kits.
The linets are first placed into the empty sterilization tray.
The instruments are then placed onto the Cygnus liner (or in the pouch) and the trays arc wrapped in CSR wrsp using conventional wrapping methods.
Cygnus tray liners are to be used with steam autoclave sterilization only at temperature scttings ranging between - 121°C to 134 °C.
The liners may continue to be used during the procedure as a sterile field on which to place instruments.
Upon the completion of the procedure the liners are disposed of in gccordance with applicable medical waste regulations.
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/K964256 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964256: Cygnus Instrument Protectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964256
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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