Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Span-America Medical Systems, Inc. · Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
233 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973169 | PRESSURE GUARD SITE SELECT (A) | Span-America Medical Systems, Inc. | 1998-02-20 | 179 | 0 |
| K972486 | PRESSUREGUARD IV | Span-America Medical Systems, Inc. | 1998-02-20 | 233 | 0 |
| K960188 | PRESSUREGUARD: SELECTCARE | Span-America Medical Systems, Inc. | 1996-10-02 | 260 | 0 |
| K961502 | LUBRICATING JELLY, LOW VISCOSITY | Span-America Medical Systems, Inc. | 1996-07-18 | 90 | 0 |
| K961159 | POWERED LOW AIR LOSS MATTRESS SYSTEM | Span-America Medical Systems, Inc. | 1996-06-14 | 84 | 0 |
| K960620 | PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM | Span-America Medical Systems, Inc. | 1996-04-25 | 72 | 0 |
| K960189 | GEL-T CUSHION | Span-America Medical Systems, Inc. | 1996-02-07 | 22 | 0 |
| K954766 | PRESSURE GUARD ALTERNATING PRESSURE MATTRESS | Span-America Medical Systems, Inc. | 1996-01-11 | 86 | 0 |
| K953503 | PRESSUREGUARD IV | Span-America Medical Systems, Inc. | 1995-10-24 | 90 | 0 |
| K954117 | CUSTOMCARE SEATING SYSTEM | Span-America Medical Systems, Inc. | 1995-10-13 | 42 | 0 |
| K951112 | PRESSUREGUARD IV | Span-America Medical Systems, Inc. | 1995-06-06 | 88 | 0 |
| K932681 | PRESSUREGUARD IV | Span-America Medical Systems, Inc. | 1993-11-12 | 162 | 0 |
| K893958 | BAXTER ACETONE-ALCOHOL PREP PADS, STERILE | Span-America Medical Systems, Inc. | 1989-10-03 | 124 | 0 |
| K894791 | BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE | Span-America Medical Systems, Inc. | 1989-10-03 | 67 | 0 |
| K882506 | MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0 | Span-America Medical Systems, Inc. | 1988-09-09 | 92 | 0 |
| K870742 | AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G | Span-America Medical Systems, Inc. | 1987-06-05 | 100 | 0 |
| K870718 | AMERICAN ALCOHOL PREP PAD STERILE MEDIUM | Span-America Medical Systems, Inc. | 1987-05-07 | 76 | 0 |
| K854255 | SPAN / AID SYRINGE | Span-America Medical Systems, Inc. | 1985-11-12 | 21 | 0 |
| K801518 | SPAN-AID BRIDGING PILLOW SYSTEM | Span-America Medical Systems, Inc. | 1980-08-04 | 34 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda