510(k) · Cleared
ClearedOR Specific Big Case Back Table Cover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Or Specific, Inc. · KKX Drape, Surgical, Antimicrobial
Cleared on Jul 24, 2006 as substantially equivalent to K050322 (Microtek Medical, Inc., 2005) and 1 other predicate after a 300-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jul 24, 2006
- Review
- 300 days
- Class
- Class II
- Product code
- KKX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K931417 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931417 | Sterile Equipment Covers | Custom Medical Products, Ltd. | 1995 | — |
| −1 | K050322 | Microtek Equipment Drapes | Microtek Medical, Inc. | 2005 | 17 |
| 0 (this device) | K052668 | OR Specific Big Case Back Table Cover | Or Specific, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 KKX? 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 KKX device
- #1 K222578 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise…score 5.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050322 | Microtek Equipment DrapesSummary page 2…ing normal use Inadvertent puncture of the cover resulting in contamination during normal use Legally Marketed Predicate Devices: Microtek Medical, Inc. Equipment Drapes K050322 Medline Band Bags and Equipment Drapes K0302065 Custom Medical Products Equipment Drapes K931417 DEPARTMENT OF HE… | 2005 |
| Kept off the family tree | K030206 | FDA’s K030206 is APEX 90 Our reading of the summary gave K030206, FDA’s number for APEX 90 (We Dong Myung Dental Industrial Co., Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Medline Band Bags and Equipment Drapes”. Kept off the family tree. Summary page 2…r resulting in contamination during normal use Legally Marketed Predicate Devices: Microtek Medical, Inc. Equipment Drapes K050322 Medline Band Bags and Equipment Drapes K0302065 Custom Medical Products Equipment Drapes K931417 DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2003 |
| * | K931417 | Sterile Equipment CoversSummary page 2…ally Marketed Predicate Devices: Microtek Medical, Inc. Equipment Drapes K050322 Medline Band Bags and Equipment Drapes K0302065 Custom Medical Products Equipment Drapes K931417 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 1995 |
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 3 companies; a new generation was cleared every 9.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 5 other devices also cite its predicate K050322.
How does its category compare?
All KKX devicesKKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KKX
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · KKX
182in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KKX
2in 2024
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KKX
24in 2025
MAUDE reports naming product code KKX, 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 | 4 | 181 | 1 | 24 |
| 2008 | 5 | 164 | 0 | 24 |
| 2009 | 5 | 114 | 0 | 27 |
| 2010 | 8 | 107 | 1 | 25 |
| 2011 | 4 | 147 | 1 | 57 |
| 2012 | 2 | — | 1 | 40 |
| 2013 | 3 | 227 | 7 | 63 |
| 2014 | 6 | 182 | 7 (7) | 28 |
| 2015 | 2 | — | 0 | 33 |
| 2016 | 0 | — | 4 | 56 |
| 2017 | 1 | — | 0 | 30 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 0 | — | 0 | 41 |
| 2020 | 1 | — | 0 | 16 |
| 2021 | 1 | — | 0 | 41 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 2 | — | 0 | 32 |
| 2024 | 0 | — | 2 | 19 |
| 2025 | 0 | — | 0 | 24 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The OR Specific, Inc. Big Case Back Table Cover is a single use, sterile packaged operating room equipment drape that is intended to provide and maintain a barrier against contamination between the OR Specific dual adjustable shelf operating room equipment tables and a variety of surgical and non surgical equipment during various procedures in the clinical and hospital operating room environment. In normal use as directed this product will not make…
Read the full statement (197 words)
The OR Specific, Inc. Big Case Back Table Cover is a single use, sterile packaged operating room equipment drape that is intended to provide and maintain a barrier against contamination between the OR Specific dual adjustable shelf operating room equipment tables and a variety of surgical and non surgical equipment during various procedures in the clinical and hospital operating room environment. In normal use as directed this product will not make direct contact with a patient. The drape is available 4 models to meet user requirements.
Part Number Description
420HD-S Big Case Back Table Cover (Heavy Duty) for 6' long Table (Sterile)
420-S Big Case Back Table Cover (Standard) for 6' Long Table (Sterile)
419HD-S Big Case Back Table Cover (Heavy Duty) for 5' Long Table (Sterile)
419-S Big Case Back Table Cover (Standard) for 5' Long Table (Sterile)
Drapes are available in two lengths to fit 5 foot long and 6 foot long OR Specific dual adjustable shelf operating room equipment tables and each length of Drape is available in a Standard and Heavy Duty version differing in the thickness and composition of the poly film fluid barrier material used in the construction of the drape.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052668 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052668: OR Specific Big Case Back Table Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052668
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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