510(k) · Cleared
ClearedPresbyterian Linen Services Surgical Packs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · LRO General Surgery Tray
Cleared on Mar 10, 1997 as substantially equivalent to K932522 (Amsco Sterile Recoveries, Inc., 1994) and 2 other predicates after a 45-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Mar 10, 1997
- Review
- 45 days
- Class
- Class II
- Product code
- LRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K930700 (1993). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK930700 Medlines Repeat Performance Surgical Pack SystemMedline Industries, Inc. · 1993
- This deviceK970286 Presbyterian Linen Services Surgical PacksMedline Industries, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930700 | Medlines Repeat Performance Surgical Pack System | Medline Industries, Inc. | 1993 | — |
| 0 (this device) | K970286 | Presbyterian Linen Services Surgical Packs | Medline Industries, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 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 LRO? 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 LRO device
- #1 K212258 Medline Cardiovascular Procedure Kitscore 2.5 · 1 generation · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K932522 | Amsco Sterile Recoveries Surgical PacksSummary page 1…643 Contact Person: Lara N. Simmons See Attached Letter of Authorization Presbyterian Linen Services’ Surgical Packs are substantially equivalent to the following: 1. K932522 AMSCO Sterile Recoveries Surgical Packs 2. K935199 Associated Hospital Services, Inc. Surgical Packs 3. K930700 Medline’s Repeat… | 1994 |
| * | K935199 | Surgical ApparelSummary page 1…etter of Authorization Presbyterian Linen Services’ Surgical Packs are substantially equivalent to the following: 1. K932522 AMSCO Sterile Recoveries Surgical Packs 2. K935199 Associated Hospital Services, Inc. Surgical Packs 3. K930700 Medline’s Repeat Performance Surgical Pack System Presbyterian Line… | 1994 |
| * | K930700 | Medlines Repeat Performance Surgical Pack SystemSummary page 1…Packs are substantially equivalent to the following: 1. K932522 AMSCO Sterile Recoveries Surgical Packs 2. K935199 Associated Hospital Services, Inc. Surgical Packs 3. K930700 Medline’s Repeat Performance Surgical Pack System Presbyterian Linen’s Surgical Packs are virtually identical to the predicate d… | 1993 |
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?
- None of the 3 ancestors has a recall.
How does its category compare?
All LRO devicesLRO General Surgery Tray: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LRO
Too few LRO 510(k)s in any year since 2007 to give a median.
Recalls per year · LRO
14in 2025
Class I (93 since 2007) Class II/III not classified
Adverse event reports per year · LRO
5,488in 2025
MAUDE reports naming product code LRO, 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 | — | 1 | 8 |
| 2008 | 0 | — | 0 | 8 |
| 2009 | 0 | — | 2 | 5 |
| 2010 | 0 | — | 1 | 23 |
| 2011 | 0 | — | 11 | 17 |
| 2012 | 0 | — | 4 | 64 |
| 2013 | 0 | — | 11 (11) | 25 |
| 2014 | 0 | — | 59 (58) | 59 |
| 2015 | 0 | — | 5 | 628 |
| 2016 | 0 | — | 4 | 805 |
| 2017 | 0 | — | 29 | 523 |
| 2018 | 0 | — | 31 | 384 |
| 2019 | 0 | — | 4 | 406 |
| 2020 | 0 | — | 3 | 767 |
| 2021 | 1 | — | 3 | 920 |
| 2022 | 1 | — | 192 | 1,134 |
| 2023 | 0 | — | 18 (2) | 1,913 |
| 2024 | 0 | — | 60 (1) | 3,031 |
| 2025 | 0 | — | 14 (5) | 5,488 |
| 2026 | 0 | — | 75 (16) | — |
What is it indicated for?
Presbyterian Linen Services Surgical Packs are intended to be used in various surgical procedures. The packs provide sterile gowns, drapes and towels to be used during procedures to protect both the surgical patient and the operating room personnel from transfer of microbial and other contamination. Surgical towels provide additional absorption of blood and body fluids when used to square off a surgical site, or may be used by operating room personnel for drying of hands after scrubbing.
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/K970286 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970286: Presbyterian Linen Services Surgical Packs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970286
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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