510(k) · Cleared
ClearedBioshield Express Sterilization Wrap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allegiance Healthcare Corp. · FRG Wrap, Sterilization
Cleared on Aug 25, 1999 as substantially equivalent to K770933 (Convertors, 1977) after a 308-day review. Its family tree reaches back 1 generation to 1977. 1 later device descends from it.
- Decided
- Aug 25, 1999
- Review
- 308 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K770933 (1977). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK770933 Bio-Shield CSR WrapConvertors · 1977
- This deviceK983719 Bioshield Express Sterilization WrapAllegiance Healthcare Corp. · 1999
- Descendant · cites it directly · 0 of its ownK993871 Bioshield Heavy Duty and Super Duty Express Sterilization WrapAllegiance Healthcare Corp. · 2000
Most influential descendants
Showing 1 of 1 · See all- K993871Bioshield Heavy Duty and Super Duty Express Sterilization WrapAllegiance Healthcare Corp. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K770933 | Bio-Shield CSR Wrap | Convertors | 1977 | — |
| 0 (this device) | K983719 | Bioshield Express Sterilization Wrap | Allegiance Healthcare Corp. | 1999 | — |
| +1 | K993871 | Bioshield Heavy Duty and Super Duty Express Sterilization Wrap | Allegiance Healthcare Corp. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 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? (4)
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 |
|---|---|---|---|
| * | K770933 | Bio-Shield CSR WrapSummary page 1…duct Trade Name: Allegiance BijoShield® Express™ Sterilization Wrap Common Name: CSR Wrap or Sterilization Wrap Classification: Sterilization Wrap Predicate Device: (K770933) Description: Intended Use: Allegiance BioShield® Sterilization Wrap The Allegiance BioShield® Express™ Sterilization Wrap is… | 1977 |
| * | — | Dextex II Sterilization Wrap Named without a submission number | |
| * | — | Kimguard™ Sterilization Named without a submission number | |
| * | — | Allegiance BioShield® Sterilization Wrap Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993871 | Bioshield Heavy Duty and Super Duty Express Sterilization Wrap | 2000 | 0 |
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.
- Of its descendants, K993871 (Allegiance Healthcare Corp., 2000) has gone furthest, with 0 descendants of its own.
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 Bioshield® Express™ Sterilization Wrap is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
This wrap is intended for use in prevacuum steam sterilization processes.
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/K983719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983719: Bioshield Express Sterilization Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983719
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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